Actively Recruiting
Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Led by IRCCS San Raffaele · Updated on 2021-10-04
100
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official 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
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
P
Pier Alberto Testoni, MD, Prof.
CONTACT
S
Sabrina Gloria Giulia Testoni, MD, PhD
CONTACT
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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