Comparing Stretta procedure to conservative treatment for GERD
Endoscopic Treatment of Gastro-esophageal Reflux Disease with Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study
NA · Military University Hospital, Prague · NCT05781347
This study is testing if the Stretta procedure, which uses radiofrequency energy, can help people with GERD feel better compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Military University Hospital, Prague (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT05781347 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of the Stretta procedure, a minimally invasive endoscopic therapy using radiofrequency energy, in managing gastroesophageal reflux disease (GERD) compared to conservative treatment options. Initially focused on obese patients, the study was expanded to include all patients with confirmed pathological GERD due to recruitment challenges. Participants are selected based on strict eligibility criteria, including verified symptomatic GERD and normal findings on high-resolution esophageal manometry. The aim is to improve GERD management and reduce reliance on long-term proton pump inhibitors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic GERD despite proton pump inhibitor use.
Not a fit: Patients with severe reflux esophagitis, Barrett's esophagus, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from GERD, potentially reducing their dependence on medications.
How similar studies have performed: Other studies have shown promise for the Stretta procedure in treating GERD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Prague
- Military University Hospital Prague — Prague, Czechia (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GERD