Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05066594
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05066594
Study Brief:
Protocol Section:
NCT05066594