NCT05066594 Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
| NCT ID | NCT05066594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Gastro Esophageal Reflux |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-05-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
Eligibility 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.
Contact & Investigator
Pier Alberto Testoni, Prof.
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT05066594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gastro Esophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05066594 currently recruiting?
Yes, NCT05066594 is actively recruiting participants. Contact the research team at testoni.pieralberto@hsr.it for enrollment information.
Where is the NCT05066594 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05066594 clinical trial?
NCT05066594 is sponsored by IRCCS San Raffaele. The principal investigator is Pier Alberto Testoni, Prof. at IRCCS San Raffaele. The trial plans to enroll 100 participants.