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Recruiting NCT05066594

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

— Observational Gastro Esophageal Reflux

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transoral incisionless fundoplication.
Who it may be relevant to
Registry conditions: Gastro Esophageal Reflux. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease

Overview

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.

Detailed 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.

Interventions

  • Device Transoral incisionless fundoplication
    The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.

Primary outcome measures

  • Medical use and dosage [Time frame: Yearly, up to 5 years from the date of the intervention]
Secondary outcome measures (9)
  • Health Related Quality of Life questionnaire score [Time frame: Yearly, up to 5 years from the date of the intervention]
  • Reflux Symptom Index questionnaire score [Time frame: Yearly, up to 5 years from the date of the intervention]
  • Esophagitis [Time frame: 6 months and 12 months after the date of the intervention]
  • Hill's grade of the gastro-esophageal flap valve [Time frame: 6 months and 12 months after the date of the intervention]
  • Jobe's length of the gastro-esophageal valve [Time frame: 6 months and 12 months after the date of the intervention]
  • Barrett's esophagus [Time frame: 6 months and 12 months after the date of the intervention]
  • High-resolution esophageal manometry findings [Time frame: 12 months after the date of the intervention]
  • 24-hour esophageal pH-metry findings [Time frame: 12 months and 24 months after the date of the intervention]
  • 24-hour esophageal impedancemetry findings [Time frame: 12 months and 24 months after the date of the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • IRCCS San Raffaele — Milan

Identifiers

NCT: NCT05066594 · TIF REGISTRY 2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗