Data and Bibliography

To date, the TIF procedure with the EsophyX® device has been performed in more than 30,000 patients worldwide. More than 100 peer-reviewed papers from over 75 centers have been published documenting consistent outcomes in over 1,500 unique study patients. The clinical study data demonstrate:

  • Significant control of reflux and improvement in quality of life.
  • Elimination of daily PPI therapy in 81% of patients.
  • Esophagitis completely healed in 82% of patients post TIF procedure.
  • Restores natural anatomy and restoration of function of the gastroesophageal junction.
  • Proved clinical efficacy across a range of outcome measurements, including symptoms and quality of life scores, cessation of PPI therapy, pH-metry changes, and LES pressure.
  • An excellent safety profile
    • With minimal post‐operative side‐effects, such as gas bloat and dysphagia.
    • SAE rate in more than 30,000 TIF procedures worldwide is <0.37%; last SAE reported Dec 2021

You can read more about our data by clicking on the case studies or articles from the bibliography below.

Summary of Clinical Evidence

Clinical Research – U.S.

TIF versus Medical Proton Pump Inhibitor Management of Refractory GERD Symptoms: The TEMPO Trial

ClinicalTrials.gov Identifier: NCT016437958

Publications:

  • Trad KS, Fox MA, Simoni G, Shughoury AB, Mavrelis PG, Raza R, Heise JA, Barnes WE The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective Surgical Innovation 2018 Feb 6 published online
  • Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA. Mavrelis PG. Transoral Fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with crossover arm. Surg Endosc. 2016 Sept 21 published online.
  • KS Trad, G Simoni, WE Barnes, AB Shughoury, M Raza, JA Heise, DG Turgeon, MA Fox, PG Mavrelis Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open-label, crossover study. BMC Gastroenterology 2014; 14:174.
  • Trad KS, Barnes WE, Simoni G, Shughoury AB, Mavrelis PG, Raza M, Heise JA, Turgeon DG, Fox MA. Transoral Incisionless Fundoplication Effective in Eliminating GERD Symptoms in Partial Responders to Proton Pump Inhibitor Therapy at 6 Months: The TEMPO Randomized Clinical Trial. Surg Innov. 2015 Feb;22(1):26-40.

Transoral Incisionless Fundoplication Registry Study for Treatment of Gastroesophageal Reflux Disease: The TIF Registry

ClinicalTrials.gov Identifier: NCT01118585

Publications:

  • Bell RC, Barnes WE, Carter BJ, Sewell RW, Mavrelis PG, Ihde GM, Hoddinott KM, Fox MA, Freeman KD, Gunsberger T, Hausmann MG, Dargis D, Gill BD, Wilson EB, Trad KS. Transoral Incisionless Fundoplication: 2-year results from the prospective multicenter U.S. study. Am Surg. 2014 Nov; 80(11):1093-1105.
  • Bell RC, Fox MA, Barnes WE, Mavrelis PG, Sewell RW, Carter BJ, Ihde GM, Trad KS, Dargis D, Hoddinott KM, Freeman KD, Gunsberger T, Hausmann MG, Gill BD, Wilson E. Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication. Surg Endosc. 2014 Oct;28(10):2949-58.
  • Wilson EB, Barnes WE, Mavrelis PG, Carter BJ, Bell RCW, Sewell RW, Ihde GM, Dargis D, Hoddinott KM, Shughoury AB, Gill BD, Fox MA, Turgeon DG, Freeman K, Gunsberger T, Hausmann MG, LeBlanc KA, Deljkich E, Trad KS. The Effects of Transoral Incisionless Fundoplication on Chronic GERD Patients: 12-Month Prospective Multicenter Experience. Surg Laparosc Endosc Percutan Tech. Feb 2014; 24(1):36-46.
  • Bell RCW, Mavrelis PG, Barnes WE, Dargis D, Carter BJ, Hoddinott KM, Sewell RW, Trad KS, Gill BD, Ihde GM. A Prospective Multicenter Registry of Patients with Chronic Gastroesophageal Disease Receiving Transoral Incisionless Fundoplication. J Am Coll Surg. 2012 Dec;215(6):794-809.

Randomized EsophyX Versus Sham / Placebo-Controlled TIF Trial: The RESPECT Study

ClinicalTrials.gov Identifier: NCT01136980

Publication:

  • Hunter JG, Kahrilas PJ, Bell RCW, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis K, Turgen TG, Hungness ES, Diggs BS. 2015 Feb;148(1):324-33.

Clinical Research – Europe

TIF versus Medical Proton Pump Inhibitor Management of Refractory GERD Symptoms: The TEMPO Trial

ClinicalTrials.gov Identifier: NCT016437958

Publications:

  • Trad KS, Fox MA, Simoni G, Shughoury AB, Mavrelis PG, Raza R, Heise JA, Barnes WE The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective Surgical Innovation 2018 Feb 6 published online
  • Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA. Mavrelis PG. Transoral Fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with crossover arm. Surg Endosc. 2016 Sept 21 published online.
  • KS Trad, G Simoni, WE Barnes, AB Shughoury, M Raza, JA Heise, DG Turgeon, MA Fox, PG Mavrelis Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open-label, crossover study. BMC Gastroenterology 2014; 14:174.
  • Trad KS, Barnes WE, Simoni G, Shughoury AB, Mavrelis PG, Raza M, Heise JA, Turgeon DG, Fox MA. Transoral Incisionless Fundoplication Effective in Eliminating GERD Symptoms in Partial Responders to Proton Pump Inhibitor Therapy at 6 Months: The TEMPO Randomized Clinical Trial. Surg Innov. 2015 Feb;22(1):26-40.

Future Clinical Trials

EndoGastric Solutions continues to support clinical trials and prospective research. Our mission is to support health care professionals, key opinion leaders, regulatory agencies, payers, professional groups, physicians and patients with scientific information and education that meets or exceeds quality standards. EGS believes that the current and anticipated publications on the TIF procedure as well as the future studies we are planning will ultimately assist physicians and patients to choose the most appropriate therapy. EGS is working to expand the current body of TIF clinical publications by initiating the following studies:

  • Partnering with commercial payers to assess and model the direct and indirect cost impact of traditional treatment modalities for GERD vs. TIF procedures
  • Investigator-initiated trials on specific GERD symptom domains following TIF procedures
  • Internal R&D studies

Bibliography

 
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