Clinical Research

Since its inception in 2003, EndoGastric Solutions (EGS) has been dedicated to the continued pursuit of robust clinical research evidence supporting the management of GERD symptoms and the TIF procedure with the EsophyX device®. Currently, more than 80 peer-reviewed papers from over 60 centers have been published documenting consistent outcomes on over 1,300 unique TIF patients.

The following are ongoing and completed studies:

Clinical Research – U.S.

TIF versus Medical Proton Pump Inhibitor Management of Refractory GERD Symptoms: The TEMPO Trial
ClinicalTrials.gov Identifier: NCT016437958
Status:

• Enrollment closed
• Study is ongoing

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-yar 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 Gastroenterology2014; 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

Status:

• Enrollment closed
• Study is ongoing

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

Status:

• Enrollment closed
• Study is ongoing

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

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

Status:

• Enrollment closed
• Study is ongoing

Publication:

• B. Håkansson, M. Montgomery, G. B. Cadiere, A. Rajan, S. Bruley des Varannes, M. Lerhun, E. Coron, J. Tack, R. Bischops, A. Thorell, U. Arnelo, L. Lundell Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther 2015 Dec;42(11-12):1261-70.

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

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Image: NP02395-01H