Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial

Gastroenterology. 2005 Mar;128(3):532-40. doi: 10.1053/j.gastro.2004.12.005.


Background & aims: This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure.

Methods: In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months.

Results: The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001).

Conclusions: Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cardia
  • Endoscopy, Digestive System
  • Esophagus
  • Female
  • Gastroesophageal Reflux / metabolism
  • Gastroesophageal Reflux / therapy*
  • Humans
  • Hydrogen-Ion Concentration
  • Injections
  • Male
  • Middle Aged
  • Polyvinyls / administration & dosage*
  • Polyvinyls / adverse effects
  • Polyvinyls / therapeutic use
  • Prognosis
  • Prospective Studies
  • Prostheses and Implants* / adverse effects
  • Retreatment
  • Single-Blind Method
  • Time Factors
  • Treatment Outcome


  • Polyvinyls
  • ethylene-vinyl alcohol copolymer