Overview

About Our Clinical Research

Executive Summary

• TIF has been used in over 10,245 cases worldwide. Click here for a complete list of published peer-reviewed articles and abstracts.
• Two randomized trials in Europe and the U.S. and a 500-patient U.S. TIF Registry are underway.
• Clinical trials have demonstrated that:
  • TIF is safe with a complication rate not exceeding 0.1%.
  • TIF restores the anatomy and functions of the gastroesophageal junction.
  • Clinical efficacy has been proven measuring:
  • Symptoms and quality of life
  • Use of PPIs (Proton Pump Inhibitors, or acid-suppressive pharmaceuticals)
  • Impedance
  • pH-metry
  • Manometry
• TIF improves significantly typical symptoms such as heartburn and regurgitation in 75-89% of patients.
• TIF eliminates refractory to medical therapy atypical symptoms such as cough and hoarseness in 72-90% of patients.
• TIF eliminates the need for daily medical therapy (mainly PPIs) in up to 97% of patients.
• Discontinuation of daily PPIs after TIF is associated with significantly:
• Increased LES pressure
• Reduced acid reflux episodes
• Reduced proximal extent of refluxate
• TIF results in 61% normalization of esophageal acid exposure and 89% normalization of reflux episodes.
• Long-term results support TIF valve durability and its effectiveness in controlling gastroesophageal reflux in over 80% of patients.
• The clinical results to date support the safety of TIF and its efficacy in eliminating typical and atypical symptoms, reducing daily use of medication, normalizing acid reflux, and curing GERD in over 75% of patients.
• EGS maintains an extensive database of all clinical and pre-clinical research information.

About Our Results

European TIF Results

Two studies were conducted in Europe to evaluate the safety and long-term efficacy of the TIF gastro-gastric procedure: The first one was a single-center study with 19 patients; and the second was a multicenter study with 86 patients. Both studies demonstrated the safety of the TIF procedure and provided the first long-term efficacy results (see table below).

1 Cadiere et al (2008) Surg Endosc 22:333-42                   A Results for the same 54 patients
2 Cadiere et al (2009) Surg Endosc 23: 957-64                  B Patients with normalized pH at 1 yr
3 Muls et al (in prepation)

U.S. TIF Results

The TIF esophago-gastric procedure was introduced in late 2008 and the initial U.S. results report excellent objective and subjective outcomes (see table below).

1 Bell & Freeman Surg Endosc (published online Dec13, 2010)                                                             
2 Barnes et al Surg Innovation (in press)
A Preliminary unpublished results included in abstracts submitted to SAGES 2011 or DDW 2011

About Our Research

European Clinical Research Studies

Transoral Incisionless Fundoplication Versus Sham for Treatment of Gastroesophageal Reflux Disease: the TIF vs Sham Study
ClinicalTrials.gov Identifier: NCT01110811

U.S. Clinical Research Studies

Transoral Incisionless Fundoplication Registry Study for Treatment of Gastroesophageal Reflux Disease: The TIF Registry
ClinicalTrials.gov Identifier: NCT01118585

Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
ClinicalTrials.gov Identifier: NCT01136980

NP01964-01C