Registry for Transoral Incisionless Fundoplication for GERD
Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
This study tracks how well a new procedure called transoral incisionless fundoplication works for people with GERD by looking at their symptoms and quality of life over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05066594 on ClinicalTrials.gov |
What this trial studies
This observational registry records the outcomes of transoral incisionless fundoplication (TIF) in patients suffering from gastroesophageal reflux disease (GERD) with various symptoms. It aims to monitor therapy responses by assessing changes in proton pump inhibitor usage and quality of life through standardized questionnaires over a 5-year follow-up period. The study will also characterize the patient population and identify predictive factors for successful TIF outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic gastroesophageal reflux disease who are clinically indicated for TIF and can commit to a 5-year follow-up.
Not a fit: Patients without a clinical indication for TIF or those unable to participate in the long-term follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of TIF for GERD, potentially improving treatment options for patients.
How similar studies have performed: Other studies have explored similar interventions, but this registry aims to provide a comprehensive observational approach to TIF outcomes, making it a valuable addition to existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for enrollment: * Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease; * Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital; * Signed informed consent for participation in the observational registry. Exclusion Criteria for enrollment: * Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease; * Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital; * No signed informed consent for participation in the observational registry.
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Pier Alberto Testoni, Prof. — IRCCS San Raffaele
- Study coordinator: Pier Alberto Testoni, MD, Prof.
- Email: testoni.pieralberto@hsr.it
- Phone: +39 02/26432756
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.