Evaluating endoscopic fundoplication for gastro-esophageal reflux
Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
This study is testing if a new endoscopic procedure can help people with gastro-esophageal reflux disease (GERD) feel better and reduce their need for medication over six years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT03669874 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the effectiveness of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSE) in patients suffering from gastro-esophageal reflux disease (GERD). The study will evaluate the impact of this procedure on patients' quality of life, reflux symptoms, and the use of proton pump inhibitors over a six-year follow-up period. It will also gather demographic and clinical data to characterize the patient population receiving this treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic GERD-related symptoms who are indicated for surgical fundoplication and can commit to long-term follow-up.
Not a fit: Patients with significant esophageal conditions, such as hiatal hernia or major motility disorders, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from GERD by reducing symptoms and reliance on medication.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating endoscopic techniques for GERD treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic (\> 6 months) GERD-related esophageal or extra-esophageal symptoms * Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus) * Indication to surgical fundoplication * Patients available for a long-term follow-up Exclusion Criteria: * Hiatal hernia ≥ 3 cm * Major esophageal motility disorder * Esophageal stenosis * Malignant neoplasia (except minor superficial skin neoplasm) * Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula * Previous cardiac, thoracic or upper GI surgery * BMI \>40 * Pregnancy or breast feeding
Where this trial is running
Milan
- Pier Alberto Testoni — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Pier Alberto Testoni, Professor — San Raffaele Scientific Institute
- Study coordinator: Pier Alberto Testoni, Professor
- Email: testoni.pieralberto@hsr.it
- Phone: +390226432756
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.