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ENTERYX® Procedure

12-Month Follow-Up of GERD Symptoms and Treatment Satisfaction

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Brown, Michael M.D.; Johnson, David A. M.D.; Pruitt, Ron M.D.; Ganz, Robert A. M.D.; Radwin, Martin M.D.; Mendolia, Thomas DO; Vakil, Nimish M.D.; Gostout, Christopher J. M.D.; DeLegge, Mark M.D.; Pleskow, Douglas K. M.D.; Chen, Yang K. M.D.

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue - p S47–S48
Supplement Abstracts Submitted for the 70th Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS
Free

Department of Gastroenterology, Rush University Medical Center, Chicago, IL; Eastern Virginia Medical School, Norfolk, VA; Nashville Medical Research Institute, Nashville, TN; Abbott-Northwestern Hospital, Minneapolis, MN; Pioneer Valley Hospital, West Valley City, UT; Northwest Piedmont Clinical Research, Inc., Elkin, NC; University of Wisconsin Medical School, Milwaukee, WI; Mayo Clinic Rochester, Rochester, MN; Medical University of South Carolina, Charleston, SC; Beth Israel Deaconess Medical Center, Boston, MA and University of Colorado Hospital, Aurora, CO.

Purpose: To evaluate GERD symptoms and treatment satisfaction prior to and 12 months following the ENTERYX Procedure.

Methods: Patients with GERD, responsive to PPIs participated in two ongoing post-market studies to evaluate treatment outcomes with the ENTERYX Procedure. GERD symptoms (Velanovich GERD-HRQL) and treatment satisfaction were assessed at baseline on PPIs and months 1, 6, 12, 24, and 36 post-procedure. Treatment satisfaction regarding symptom control, relief, freedom to eat and drink, sleep improvement, and overall rating was assessed using a GERD-specific questionnaire. Paired t-tests comparing baseline and follow-up scores were performed for evaluable patients.

Results: 59% (202/343), and 18% (61/343) of patients have completed 6 and 12-month follow-up respectively. Mean age is 49 ± 13.2 years; 49% of patients is male. Prior to treatment, mean GERD-HRQL score for the 199 patients with 6-month follow-up was 19.7 compared to 9.6 at 6 months (p < 0.05;95% CI: 8.6,11.5). For the 60 patients with 12-month follow-up, mean baseline GERD-HRQL score was 20.6 compared to 13.0 at 12 months (p < 0.05;95% CI: 4.5,10.8). Treatment satisfaction results are presented below.

Conclusions: Interim data from these ongoing post-market studies suggest that following ENTERYX, patients are more satisfied with treatment benefits and have improved GERD symptoms as compared to baseline on PPIs.

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