Stretta Versus Conservative Treatment in Obese and Non-obese

Sponsor
Military University Hospital, Prague (Other)
Overall Status
Recruiting
CT.gov ID
NCT05781347
Collaborator
(none)
60
1
4
40
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency Energy to the LES (Stretta Procedure)
  • Device: Stretta
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be devided into 2 groups (obese and non-obese). Each group will be randomized (ratio 1:1) into 2 subgroups receiving the therapy (Stretta : Conservative/PPI)Patients will be devided into 2 groups (obese and non-obese). Each group will be randomized (ratio 1:1) into 2 subgroups receiving the therapy (Stretta : Conservative/PPI)
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Obese patients receiving Stretta

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.

No Intervention: Obese patients receiving Conservative therapy/PPI

Active Comparator: Non-obese patients receiving Stretta

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.

No Intervention: Non-obese patients receiving Conservative treatment/PPI

Outcome Measures

Primary Outcome Measures

  1. PPI usage [6 and12 months]

    Stopping PPI use or reducing PPI dose by more than 50 % in patients

  2. GERD Health Related Quality of Life (GERD-HRQL) questionaire [6 and 12 months]

    Achievement at least a 50 % reduction in symptoms during the initial 12 month as compared to baseline

  3. Reflux Severity Index (RSI) score [6 and12 months]

    Achievement at least a 50 % reduction in symptoms during the initial 12 month as compared to baseline

Secondary Outcome Measures

  1. 24h pH-metry with impedance [6 and 12 months]

    Achievment at least a 50 % reduction in pH-metric parameters (Acid Exposure Time - AET)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Military University Hospital Prague Prague Czechia

Sponsors and Collaborators

  • Military University Hospital, Prague

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katerina Kostalova, MD, Principal Investigator, Military University Hospital, Prague
ClinicalTrials.gov Identifier:
NCT05781347
Other Study ID Numbers:
  • 108/17-12/2022
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Mar 23, 2023