NCT07395219

European TIF2.0 Registry

Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cleveland Clinic London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastro -Oesophagal Reflux
• Laryngo-pharyngeal Reflux

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2030-01-01
• Completion: 2030-08-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

7 sites across 7 countries: Austria, Italy, Serbia, Switzerland, Turkey (Türkiye), United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated device study