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European TIF2.0 Registry
Sponsor: Cleveland Clinic London
Summary
This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with gastro-oesophageal reflux disease (GORD).
Official title: Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-01-01
Completion Date
2030-08-01
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device
Transoral Incisionless Fundoplication (TIF): The TIF procedure is an endoscopic, minimally invasive intervention designed to reconstruct the gastro-oesophageal valve and restore its function as a reflux barrier, without external incisions. The procedure is performed transorally using the EsophyX device under general anaesthesia. The device enables the creation of a 270° to 300° esophagogastric fundoplication. Concomitant TIF (cTIF): The cTIF procedure combines a laparoscopic hiatal hernia repair with the TIF performed in the same session. Patients with a hiatal hernia greater than 2 cm undergo laparoscopic reduction and crural repair, followed immediately by the TIF procedure using the EsophyX device. This combined approach addresses both the anatomical defect of the hiatal hernia and the functional deficiency of the gastro-oesophageal valve.
Locations (7)
Department of General Surgery, Medical University of Vienna
Vienna, Austria
Gemelli Isola
Rome, Italy
University Hospital for Digestive Surgery
Belgrade, Serbia
Intesto
Bern, Switzerland
Memorial bahçelievler hospital
Istanbul, Turkey (Türkiye)
Cleveland Clinic
Abu Dhabi, United Arab Emirates
Cleveland Clinic London
London, United Kingdom