Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Launched by IRCCS SAN RAFFAELE · Sep 24, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a procedure called transoral incisionless fundoplication (TIF) to help people suffering from gastroesophageal reflux disease (GERD). GERD is a condition where stomach acid frequently flows back into the tube connecting your mouth and stomach, causing discomfort and other symptoms. The goal of this study is to gather information on how patients respond to TIF, particularly in how it affects their use of medication to reduce stomach acid and their overall quality of life. Researchers want to understand which patients are most likely to benefit from this treatment.
To participate, you need to be diagnosed with chronic GERD and be able to commit to follow-up visits for five years at San Raffaele Hospital. You will also need to provide your consent to be part of the study. If you join, you can expect to be monitored over time to see how well the TIF procedure works for you, including any changes in your symptoms and medication use. This study is currently recruiting participants of all genders, aged between 18 and 80 years, who meet the eligibility requirements.
Gender
ALL
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.
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Trial Officials
Pier Alberto Testoni, Prof.
Principal Investigator
IRCCS San Raffaele
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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