Stretta Versus Conservative Treatment in Obese and Non-obese

GERD Clinical Trial

Official title:

Endoscopic Treatment of Gastro-esophageal Reflux Disease With Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment in Obese and Non-obese Population, Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781347
• Other study ID #: 108/17-12/2022
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Military University Hospital, Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. One of the main risk factor is obesity. Currently, either conservative treatment including pharmacotherapy and lifestyle modifications or surgical treatment are the only therapeutic options available in the Czech Republic, both approaches having their known limitations. Stretta is a minimally invasive endoscopic therapy using the radiofrequency energy delivered to the EGJ and cardia to eventually enhance the antireflux barrier.

This study will attempt to get information regarding the treatment of GERD using Stretta in the Czech Republic and correlate results in obese and non-obese population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Verified symptomatic GERD using PPI but with persistent symptoms or like to discontinue or are intolerant to them

• Positive 24h pH-metry for pathological GE reflux

• Normal finding on HR esophageal manometry according to CCv4.0

• Age over 18

• Signed informed consent with the trial and invasive procedures

Exclusion Criteria:

• Active severe reflux esophagitis (LA classification grade C - D)

• Barrett's esophagus

• Esophageal peptic stricture, eosinophilic esophagitis

• Hiatal hernia more than 2 cm

• Malignancies

• Abnormal HR esophageal manometry

• Esophageal and subcardial varices

• Pregnancy

• Severe comorbidities and increased perioperative risk

Related Conditions & MeSH terms

• GERD

Intervention

Procedure:
• Radiofrequency Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under general anesthesia which uses radiofrequency (RF) energy delivered to the lower esophageal sphincter and cardia.

Device:
• Stretta
Stretta is a FDA approved device for the management of GERD.

Locations

Country	Name	City	State
Czechia	Military University Hospital Prague	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proton pump inhibitors (PPI) use	Cessation or reducing the dose of PPI by at least 50% from baseline	6 months
Primary	Proton pump inhibitors (PPI) use	Cessation or reducing the dose of PPI by at least 50% from baseline	12 months
Primary	GERD Health Related Quality of Life questionaire	Change in symptom severity assessed by validated reflux questionnaire	6 months
Primary	GERD Health Related Quality of Life questionaire	Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)	12 months
Primary	Reflux Severity Index score	Change in symptom severity assessed by validated reflux questionnaire	6 months
Primary	Reflux Severity Index score	Change in symptom severity assessed by validated reflux questionnaire	12 months
Secondary	24h pH-metry with impedance	Change in pH-metric parameters (Acid Exposure Time - AET)	6 months
Secondary	24h pH-metry with impedance	Change in pH-metric parameters (Acid Exposure Time - AET)	12 months
Secondary	EndoFlip - distensibility of EG junction	Change in EG junction distensibility	3 months
Secondary	EndoFlip - distensibility of EG junction	Change in EG junction distensibility	12 months