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• W2166504553 abstract "Purpose: Enteryx® (ethylene vinyl alcohol) is a biocompatible co-polymer recently approved for the endoscopic treatment of gastroesophageal reflux disease (GERD) symptoms. It is injected at the gastroesophageal junction and intended to modify the distensibility of the LES, resulting in a reduction of reflux events. During an average treatment, 6-8 ml of Enteryx are administered during 4-6 injections. The co-polymer may be distributed in the shape of a bleb, arc, or a ring within the plane of the circular muscle. The effect of implant shape on the clinical effectiveness of this treatment is presently unknown. Methods: The study population consisted of 88 treated patients with implant shape data and clinical follow-up at 12 months from a cohoort of 144 patients treated in a U.S. IDE multicenter clinical trial of Enteryx. Patients receiving re-treatment or without 12 month follow-up were excluded from the evaluation. Patient inclusion and exclusion criteria, specifics of endoscopic technique, and outcomes have been previously published (Am J Gastro 2003;99:250). For each patient, the physician reported the total volume implanted as well as the fraction implanted as discrete blebs, arcs, or rings in the LES muscle. Improvement in 12 month outcome was analyzed as a function of the percent of each type of implant configuration present during implantation. Results: The following table lists the p-values from logistic regression analyses of study outcomes versus the percentage of injections of various shapes corrected for the total volume and number of injections. The higher p-values (p>0.05) in the table showed no significance in the effects of various implant shape on the elimination or improvement in PPI use (>50% reduction), GERD-HRQL symptom score, and pH-metry outcomes at 12 months. Conclusion: After 1 year, the Enteryx procedure appears to be equally effective for various configurations of the Enteryx implant into the muscle of the lower esophageal sphincter (LES). The extended effectiveness of Enteryx was not shown to be dependent on the radiologic pattern evident at the time of implantation. However, further studies may reveal additional information on the distribution of implant shape and its relationship to clinical outcome." @default.
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• W2166504553 date "2004-04-01" @default.
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• W2166504553 title "Correlation Between Clinical Outcome and Enteryx® Implant Shape" @default.
• W2166504553 doi "https://doi.org/10.1016/s0016-5107(04)00715-1" @default.
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