NCT01327963

Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: EndoGastric Solutions · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

Detailed description

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DEVICE	Transoral Incisionless Fundoplication	Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-04-04
• Last updated: 2020-12-03
• Results posted: 2020-12-03

Locations

2 sites across 1 country: United States