Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Executive Summary Aims and Hypotheses of the Study: The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life. Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20 Inclusion Criteria: 18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss. Exclusion Criteria: Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient. Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA) Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay

Primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Patients also demonstrate a weight regain of 15% of excess body weight loss.

StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.

Inclusion Criteria: Age 18-70 years BMI 35 or greater with one or more comorbidities At least 2 years post-Roux-en-Y gastric bypass surgery At enrollment, has regained at least 15% of excess body weight loss Enlarged Stoma Diameter Enlarged gastric pouch Completed successful nutritional screening and compliant with nutritional programs Completed successful cardiopulmonary evaluation Patient willing to cooperate with follow-up assessment tests Signed informed consent Exclusion Criteria: Esophageal stricture or any anatomic conditions that preclude passage of transoral endoluminal instruments Has another causal factor for weight regain other than stoma or pouch dilatation such as non compliant with nutritional and exercise programs Portal hypertension Coagulation disorders or chronic use of anticoagulants Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient

Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc. 2006 Nov;20(11):1744-8. doi: 10.1007/s00464-006-0045-0. Epub 2006 Oct 5.

Elder KA, Wolfe BM. Bariatric surgery: a review of procedures and outcomes. Gastroenterology. 2007 May;132(6):2253-71. doi: 10.1053/j.gastro.2007.03.057.

Fernandez AZ Jr, DeMaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc. 2004 Feb;18(2):193-7. doi: 10.1007/s00464-003-8926-y. Epub 2003 Dec 29.

Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000 Dec;10(6):509-13. doi: 10.1381/096089200321593706.

Gould JC, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new minimally invasive bariatric surgery program. Obes Surg. 2004 May;14(5):618-25. doi: 10.1381/096089204323093381.

Higa KD, Boone K, Nimeri A, Tercero F, Jackson A, Khan A. Gastric bypass: increased restriction for poor weight loss. Surg Endosc. 2007 Nov;21(11):1922-3. doi: 10.1007/s00464-007-9540-1. No abstract available.

Kaplan LM, Klein S, Boden G, Brenner DA, Gostout CJ, Lavine JE, Popkin BM, Schirmer BD, Seeley RJ, Yanovski SZ, Cominelli F. Report of the American Gastroenterological Association (AGA) Institute Obesity Task Force. Gastroenterology. 2007 May;132(6):2272-5. doi: 10.1053/j.gastro.2007.03.061. No abstract available.

Overcash WT. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obes Surg. 2008 Jul;18(7):882-5. doi: 10.1007/s11695-008-9452-8. Epub 2008 Apr 26.

Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.

Cadiere GB, Rajan A, Germay O, Himpens J. Endoluminal fundoplication by a transoral device for the treatment of GERD: A feasibility study. Surg Endosc. 2008 Feb;22(2):333-42. doi: 10.1007/s00464-007-9618-9. Epub 2007 Dec 11.

Cadiere GB, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK. Endoluminal fundoplication (ELF)--evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15(6):348-55. doi: 10.1080/13645700601040024.

Jobe BA, O'Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJ. Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg. 2008 Jul;248(1):69-76. doi: 10.1097/SLA.0b013e31817c9630.

Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg. 2007 May;17(5):565-8. doi: 10.1007/s11695-007-9116-0. No abstract available. Erratum In: Obes Surg. 2007 Jul;17(7):996.

Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res. 2001 Feb;9(2):102-11. doi: 10.1038/oby.2001.13.

Belle SH, Berk PD, Courcoulas AP, Flum DR, Miles CW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ; Longitudinal Assessment of Bariatric Surgery Consortium Writing Group. Safety and efficacy of bariatric surgery: Longitudinal Assessment of Bariatric Surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):116-26. doi: 10.1016/j.soard.2007.01.006.

de Lauzon B, Romon M, Deschamps V, Lafay L, Borys JM, Karlsson J, Ducimetiere P, Charles MA; Fleurbaix Laventie Ville Sante Study Group. The Three-Factor Eating Questionnaire-R18 is able to distinguish among different eating patterns in a general population. J Nutr. 2004 Sep;134(9):2372-80. doi: 10.1093/jn/134.9.2372.

Karlsson J, Persson LO, Sjostrom L, Sullivan M. Psychometric properties and factor structure of the Three-Factor Eating Questionnaire (TFEQ) in obese men and women. Results from the Swedish Obese Subjects (SOS) study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1715-25. doi: 10.1038/sj.ijo.0801442.

Arnow B, Kenardy J, Agras WS. The Emotional Eating Scale: the development of a measure to assess coping with negative affect by eating. Int J Eat Disord. 1995 Jul;18(1):79-90. doi: 10.1002/1098-108x(199507)18:13.0.co;2-v.

Junghard O, Wiklund I. Validation of a four-graded scale for severity of heartburn in patients with symptoms of gastroesophageal reflux disease. Value Health. 2008 Jul-Aug;11(4):765-70. doi: 10.1111/j.1524-4733.2007.00313.x. Epub 2008 Jan 8.

Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.

Matza LS, Boye KS, Yurgin N. Validation of two generic patient-reported outcome measures in patients with type 2 diabetes. Health Qual Life Outcomes. 2007 Jul 31;5:47. doi: 10.1186/1477-7525-5-47.

De Cocker KA, De Bourdeaudhuij IM, Cardon GM. What do pedometer counts represent? A comparison between pedometer data and data from four different questionnaires. Public Health Nutr. 2009 Jan;12(1):74-81. doi: 10.1017/S1368980008001973. Epub 2008 Mar 20.