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NCT05781347 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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