Endoscopic Fundoplication With MUSE System

Gastro-esophageal Reflux Clinical Trial

Official title:

Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03669874
• Other study ID #: MUSE/2015
• Status: Recruiting
• Start date: September 16, 2015
• Est. completion date: September 2026

Study information

• Verified date: December 2020
• Source: IRCCS San Raffaele
• Contact: Pier Alberto Testoni, Professor
• Phone: +390226432756
• Email: testoni.pieralberto[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:

• Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:

• effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores

• effect on the use and dosage of proton pump inhibitors (PPI)

• feasibility and safety of the endoluminal fundoplication procedure

• Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

• 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

• 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

• Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2026
• Est. primary completion date: September 16, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms

• Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)

• Indication to surgical fundoplication

• Patients available for a long-term follow-up

Exclusion Criteria:

• Hiatal hernia = 3 cm

• Major esophageal motility disorder

• Esophageal stenosis

• Malignant neoplasia (except minor superficial skin neoplasm)

• Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula

• Previous cardiac, thoracic or upper GI surgery

• BMI >40

• Pregnancy or breast feeding

Related Conditions & MeSH terms

• Endoscopic Fundoplication
• Esophagitis, Peptic
• Gastro-esophageal Reflux
• Gastroesophageal Reflux

Intervention

Device:
• Endoscopic fundoplication
Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication. The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.

Locations

Country	Name	City	State
Italy	Pier Alberto Testoni	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 6 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 12 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 24 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 3 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 4 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 5 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	change from baseline GERD-HRQL at 6 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 6 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 12 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 24 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 3 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 4 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 5 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	change from baseline RSI at 6 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 6 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 12 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 24 months
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 3 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 4 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 5 years
Primary	To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption	Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy	change from baseline PPI consumption at 6 years
Secondary	To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.	change from baseline hiatal hernia size at 6 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.	change from baseline hiatal hernia size at 12 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in Hill's grade	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).	change from baseline Hill's grade at 6 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in Hill's grade	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).	change from baseline Hill's grade at 12 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.	change from baseline Jobe's lenght at 6 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.	change from baseline Jobe's lenght at 12 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.	change from baseline esophagitis' grade at 6 months
Secondary	To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade	Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.	change from baseline esophagitis' grade at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.	change from baseline DeMeester score at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.	change from baseline DeMeester score at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline AET at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline AET at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline longest reflux episode at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline longest reflux episode at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of refluxes greater than 5 minutes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes	parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of refluxes greater than 5 minutes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of total refluxes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of total refluxes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of acid refluxes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of acid refluxes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of weakly acid refluxes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of weakly acid refluxes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of not acid refluxes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of not acid refluxes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of proximal refluxes at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline number of proximal refluxes at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline MNBI at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline MNBI at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline PSPW at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline PSPW at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline BCT at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)	parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	change from baseline BCT at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES basal pressure at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES basal pressure at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES lenght at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES lenght at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES IRP at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline LES IRP at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline DCI at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline DCI at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of peristaltic waves at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of peristaltic waves at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of weak waves at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of weak waves at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of fragmented waves at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of fragmented waves at 12 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of failed waves at 6 months
Secondary	To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves	parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.	change from baseline rate of failed waves at 12 months