Stretta Versus Conservative Treatment

NCT05781347 | Recruiting FDA Device

• 1 other identifier: 108/17-12/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. Obesity is a significant risk factor for GERD; however, treatment outcomes in obese patients remain challenging. In the Czech Republic, therapeutic options are currently limited to conservative treatment, including pharmacotherapy and lifestyle modifications, or surgical interventions, both of which have known limitations. Stretta is a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, aimed at enhancing the antireflux barrier. This study evaluates the effectiveness and safety of the Stretta procedure compared to conservative treatment in managing GERD. Initially designed to compare outcomes between obese and non-obese populations, the study was expanded to include all GERD patients due to recruitment challenges and the need to meet strict eligibility criteria. These criteria ensure reliable results by focusing on patients with confirmed pathological GERD while excluding those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as hypersensitivity. The study aims to provide comprehensive data on the use of Stretta in the Czech Republic and its role in GERD management.

Conditions

GERD

Outcome Measures

Primary Outcomes (6)

• Proton pump inhibitors (PPI) use

  Cessation or reducing the dose of PPI by at least 50% from baseline

  6 months

• Proton pump inhibitors (PPI) use

  Cessation or reducing the dose of PPI by at least 50% from baseline

  12 months

• GERD Health Related Quality of Life questionaire

  Change in symptom severity assessed by validated reflux questionnaire

  6 months

• GERD Health Related Quality of Life questionaire

  Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)

  12 months

• Reflux Severity Index score

  Change in symptom severity assessed by validated reflux questionnaire

  6 months

• Reflux Severity Index score

  Change in symptom severity assessed by validated reflux questionnaire

  12 months

Secondary Outcomes (2)

• 24h pH-metry with impedance

  6 months

• 24h pH-metry with impedance

  12 months

Study Arms (2)

Patients receiving Stretta

ACTIVE COMPARATOR

Procedure: Radiofrequency Energy to the LES (Stretta Procedure); Device: Stretta

Patients receiving Conservative therapy/PPI

NO INTERVENTION

Interventions

Radiofrequency Energy to the LES (Stretta Procedure) PROCEDURE

The Stretta procedure is an endoscopic treatment performed under general anesthesia. It utilizes radiofrequency (RF) energy delivered to the lower esophageal sphincter (LES) and the gastric cardia to enhance the antireflux barrier.

Patients receiving Stretta

Stretta DEVICE

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

Patients receiving Stretta

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified symptomatic GERD despite PPI use, with persistent symptoms, desire to discontinue PPIs, or intolerance to them.
• Pathological gastroesophageal reflux confirmed by positive 24-hour pH-metry with impedance.
• Normal findings on high-resolution esophageal manometry (HRM) according to CCv4.0.
• Age ≥ 18 years. Signed informed consent for participation in the trial and invasive procedures.

You may not qualify if:

• Active severe reflux esophagitis (Los Angeles classification grade C or D). Barrett's esophagus. Esophageal peptic stricture or eosinophilic esophagitis. Hiatal hernia ≥ 2 cm. Malignancies. Abnormal findings on high-resolution esophageal manometry. Esophageal or subcardial varices. Pregnancy. Severe comorbidities or increased perioperative risk. Age \> 70 years due to increased perioperative risk and common comorbidities. Symptoms primarily attributable to functional dyspepsia, significant anxiety, or depression, with overlap to other disorders of gut-brain interaction (DGBI).

Sponsors & Collaborators

• Military University Hospital, Prague: lead

Study Sites (1)

Military University Hospital Prague

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized (ratio 1:1) into two groups: one receiving the Stretta therapy and the other undergoing conservative treatment with proton pump inhibitors (PPIs). The initial plan to stratify patients into obese and non-obese groups was revised due to recruitment challenges. The study now includes all eligible patients with gastroesophageal reflux disease (GERD), regardless of body weight, provided they meet the inclusion criteria.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 23, 2023
• Study Start: September 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: March 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)