European TIF2.0 Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL) — 6-months, 1-year, 2-year, 3-years, 5-, years
  Change in reflux-specific quality of life questionnaires (The GERD-HRQL used in the study is composed of 16 questions related to symptoms of heartburn, regurgitation, swallowing and overall satisfaction. Each question provides a scaled score between 0-5 (0=no symptoms, 5= Symptoms incapacitating to do daily activities) with a total score of 75.)
• Reflux symptom index (RSI) — 6-months, 1-year, 2-years, 3-years, 5-years
  Change in reflux-specific quality of life questionnaire (The RSI used in the study is composed of 9 questions related to atypical symptoms of reflux or 'LPR'. Each question provides a scaled score between 0-5 (0=no problems, 5=severe problems) with a total score of 45.)
• Proton pump inhibitor and/or histamine-2 receptor antagonist use — 6-months, 1-year, 2-years, 3-years, 5-years
  Change in acid suppression use

Trial sites (7)