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Stretta Versus Conservative Treatment

NCT05781347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-07

No results posted yet for this study

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

Interventions

PROCEDURE

Radiofrequency Energy to the LES (Stretta 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.

DEVICE

Stretta

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

Sponsors & Collaborators

  • Military University Hospital, Prague

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-01-01
Completion
2026-03-31
FDA Device
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05781347 on ClinicalTrials.gov