Stretta Versus Conservative Treatment
Endoscopic Treatment of Gastro-esophageal Reflux Disease with Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gastroesophageal reflux disease (GERD) is a significant clinical issue that substantially impairs patients' quality of life. Chronic symptoms such as heartburn, regurgitation, and chest pain, along with extraesophageal manifestations (e.g., laryngopharyngeal reflux), often drive patients-especially younger individuals-to seek effective treatment options. Many of these patients are motivated by the desire to reduce or eliminate long-term proton pump inhibitor (PPI) use, given concerns about potential side effects and dependence on medication.
The Stretta procedure, a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, has shown promise in addressing these concerns by enhancing the antireflux barrier. This study aims to evaluate the effectiveness and safety of Stretta compared to conservative treatment in improving GERD management in the Czech Republic.
Initially, the study was designed to compare outcomes between obese and non-obese populations. However, due to recruitment challenges and the need for strict inclusion criteria, it was expanded to include all patients with confirmed pathological GERD. Participants are carefully selected based on stringent eligibility criteria, including pathological GERD confirmed by 24-hour pH-metry with impedance and exclusion of those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as esophageal hypersensitivity.
The primary goal of this study is to improve patients' quality of life and reduce the reliance on chronic PPI therapy. Secondary objectives include assessing the safety profile of the Stretta procedure and its effectiveness compared to conservative management in a broader GERD population. By focusing on these outcomes, the study seeks to provide valuable insights into the role of Stretta as a therapeutic option in GERD management and its potential to fill a critical gap in current treatment modalities.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Prague, Czechia
- Recruiting
- Military University Hospital Prague
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Contact:
- Katerina Kostalova, MD
- Phone Number: +420973203076
- Email: katerina.kostalova@uvn.cz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Patients receiving Stretta
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Stretta is a FDA approved device for the management of GERD.
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.
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No Intervention: Patients receiving Conservative therapy/PPI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proton pump inhibitors (PPI) use
Time Frame: 6 months
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Cessation or reducing the dose of PPI by at least 50% from baseline
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6 months
|
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Proton pump inhibitors (PPI) use
Time Frame: 12 months
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Cessation or reducing the dose of PPI by at least 50% from baseline
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12 months
|
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GERD Health Related Quality of Life questionaire
Time Frame: 6 months
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Change in symptom severity assessed by validated reflux questionnaire
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6 months
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GERD Health Related Quality of Life questionaire
Time Frame: 12 months
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Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL)
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12 months
|
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Reflux Severity Index score
Time Frame: 6 months
|
Change in symptom severity assessed by validated reflux questionnaire
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6 months
|
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Reflux Severity Index score
Time Frame: 12 months
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Change in symptom severity assessed by validated reflux questionnaire
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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24h pH-metry with impedance
Time Frame: 6 months
|
Change in pH-metric parameters (Acid Exposure Time - AET)
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6 months
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24h pH-metry with impedance
Time Frame: 12 months
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Change in pH-metric parameters (Acid Exposure Time - AET)
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12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 108/17-12/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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