About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Radiofrequency Energy to the LES (Stretta Procedure)
Procedure/SurgeryThe 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
DeviceStretta is a FDA approved device for the management of GERD.
Treatment groups
Trial outcomes
Primary outcomes
Proton pump inhibitors (PPI) use
Cessation or reducing the dose of PPI by at least 50% from baseline
Proton pump inhibitors (PPI) use
Cessation or reducing the dose of PPI by at least 50% from baseline
GERD Health Related Quality of Life questionaire
Change in symptom severity assessed by validated reflux questionnaire
GERD Health Related Quality of Life questionaire
Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)
Secondary outcomes
24h pH-metry with impedance
Change in pH-metric parameters (Acid Exposure Time - AET)
24h pH-metry with impedance
Change in pH-metric parameters (Acid Exposure Time - AET)
Sponsors and contacts
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