Actively Recruiting
Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) for Gastroesophageal Reflux Disease
Led by IRCCS San Raffaele · Updated on 2021-10-04
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with gastro-esophageal reflux disease (GERD) who undergo transoral incisionless fundoplication (TIF) using the EsophyX device. The study aims to record TIF procedures in patients with esophageal or extra-esophageal symptoms, monitor therapy responses including changes in proton pump inhibitor use and symptom questionnaire scores, and identify patient characteristics and factors that predict TIF success. Patients treated with TIF by the EsophyX device will be enrolled in a registry and followed clinically for five years after their procedure. The intervention creates a new valve at the gastroesophageal junction using an endoscopic technique that places multiple sutures to reduce reflux, similar to surgical fundoplication. The registry involves routine post-TIF visits and examinations to track outcomes over time. Participants will be monitored through yearly assessments of medication use and dosage, along with quality of life and reflux symptom questionnaires. Additional evaluations such as esophageal examinations, grading of the gastro-esophageal valve, esophageal manometry, pH-metry, and impedancemetry will occur at specified intervals up to two years post-procedure. The total follow-up period for each participant is five years to gather long-term data on treatment effects and patient outcomes.
CONDITIONS
Brief Title
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- No 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transoral incisionless fundoplication (TIF) using the EsophyX device to create a new gastroesophageal valve through an endoscopic procedure.
1 visit (in-person)
Duration - 5 years
Participants are followed for 5 years after the TIF procedure with routine practice visits and examinations to monitor health outcomes and device performance.
Yearly visits for up to 5 years; additional visits at 6 and 12 months, and at 24 months for specific assessments
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
P
Pier Alberto Testoni, MD, Prof.
S
Sabrina Gloria Giulia Testoni, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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