Registry for Transoral Incisionless Fundoplication for GERD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.