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Clinical Trials in Czechia / NCT05781347
Recruiting Not applicable

Stretta Versus Conservative Treatment

NCT05781347 · tracked via the Priya Life Science Czechia tracker
Sponsor
Military University Hospital, Prague
Phase
Not applicable
Started
2022-09-01
Last updated
2025-01-07

Condition(s) studied

GERD

Investigational drug(s) / intervention(s)

Radiofrequency Energy to the LES (Stretta Procedure)Stretta

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.

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: 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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Military University Hospital Prague Prague Czechia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05781347 on ClinicalTrials.gov ↗ ← All trials in Czechia