Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

Paul Focken, Lawrence Cohen, Steven A. Edmundowicz, Kenneth Binmoeller, Richard I. Rothstein, Daniel Smith, Edward Lin, Nicholas Nickl, Bergein Overholt, Peter J. Kahrilas, Nimish Vakil, Ayman M. Abdel Aziz Hassan, Glen Lehman

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). Methods A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was

Original languageEnglish (US)
Pages (from-to)1387-1397
Number of pages11
JournalSurgical Endoscopy and Other Interventional Techniques
Volume24
Issue number6
DOIs
StatePublished - Jun 2010
Externally publishedYes

Fingerprint

Gastroesophageal Reflux
Prostheses and Implants
Randomized Controlled Trials
Injections
Equipment and Supplies
Heartburn
Therapeutics
Multicenter Studies

Keywords

  • Gastroesophageal reflux disease
  • Gatekeeper
  • GORD/GERD
  • Sham procedure

ASJC Scopus subject areas

  • Surgery
  • Medicine(all)

Cite this

Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease. / Focken, Paul; Cohen, Lawrence; Edmundowicz, Steven A.; Binmoeller, Kenneth; Rothstein, Richard I.; Smith, Daniel; Lin, Edward; Nickl, Nicholas; Overholt, Bergein; Kahrilas, Peter J.; Vakil, Nimish; Abdel Aziz Hassan, Ayman M.; Lehman, Glen.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 24, No. 6, 06.2010, p. 1387-1397.

Research output: Contribution to journalArticle

Focken, P, Cohen, L, Edmundowicz, SA, Binmoeller, K, Rothstein, RI, Smith, D, Lin, E, Nickl, N, Overholt, B, Kahrilas, PJ, Vakil, N, Abdel Aziz Hassan, AM & Lehman, G 2010, 'Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease', Surgical Endoscopy and Other Interventional Techniques, vol. 24, no. 6, pp. 1387-1397. https://doi.org/10.1007/s00464-009-0784-9
Focken, Paul ; Cohen, Lawrence ; Edmundowicz, Steven A. ; Binmoeller, Kenneth ; Rothstein, Richard I. ; Smith, Daniel ; Lin, Edward ; Nickl, Nicholas ; Overholt, Bergein ; Kahrilas, Peter J. ; Vakil, Nimish ; Abdel Aziz Hassan, Ayman M. ; Lehman, Glen. / Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease. In: Surgical Endoscopy and Other Interventional Techniques. 2010 ; Vol. 24, No. 6. pp. 1387-1397.
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