Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD) (TIF/2021)

San Donato Group (GSD)

Status: Enrolling

Conditions: Gastro Esophageal Reflux

Treatments: Device: Transoral incisionless fundoplication

Study type: Observational

Funder types: Other

Identifiers

NCT05066594

TIF REGISTRY 2021

Details and patient eligibility

About

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.

Full description

After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

100 participants in 1 patient group

Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)

Description:

Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.

Treatment:

Device: Transoral incisionless fundoplication