NCT01118585

Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: EndoGastric Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Detailed description

Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline. Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Conditions

• Gastroesophageal Reflux Disease
• Hiatal Hernia

Interventions

Type	Name	Description
PROCEDURE	TIF Procedure	The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-06-01
• Completion: 2018-12-01
• First posted: 2010-05-06
• Last updated: 2019-03-06

Locations

14 sites across 1 country: United States