Shelby Sullivan1, James M Swain2,3, George Woodman4, Marc Antonetti5, Nestor De La Cruz-Muñoz6, Sreeni S Jonnalagadda7, Michael Ujiki8, Sayeed Ikramuddin9, Jaime Ponce10,11, Marvin Ryou12, Jason Reynoso2, Rajiv Chhabra7, G Brent Sorenson13, Wendell K Clarkston14, Steven A Edmundowicz15, J Christopher Eagon16, Daniel K Mullady15, Daniel Leslie9, Thomas E Lavin17, Christopher C Thompson12. 1. Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA. 2. HonorHealth Bariatric Center, Scottsdale, Arizona, USA. 3. Department of Surgery, University of Arizona School of Medicine, Scottsdale, Arizona, USA. 4. Bariatric Surgery, Baptist Weight Loss Center, Memphis, Tennessee, USA. 5. Surgery, Lexington Medical Center, West Columbia, South Carolina, USA. 6. Laparoendoscopic and Bariatric Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA. 7. Gastroenterology, St. Luke's Hospital of Kansas City (SLH), Saint Luke's GI Specialists, Kansas City, Missouri, USA. 8. Bariatric Surgery, NorthShore University Health System Evanston, Illinois, USA. 9. Bariatric Surgery, University of Minnesota, Minneapolis, Minnesota, USA. 10. Bariatrics, Chattanooga Bariatrics, Chattanooga, Tennessee, USA. 11. Hamilton Medical Center, Dalton, Georgia, USA. 12. Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts, USA. 13. Bariatric Surgery, St. Luke's Hospital of Kansas City, Kansas City, Missouri, USA. 14. Gastroenterology, University of Missouri Kansas City School of Medicine and St. Luke's Hospital of Kansas City, Kansas City, Missouri, USA. 15. Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA. 16. Surgery, Washington University School of Medicine, St. Louis, Missouri, USA. 17. Surgery, Surgical Specialists of Louisiana, Metairie, Louisiana, USA.
Abstract
OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS:Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS:Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.
RCT Entities:
OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.
Authors: Ben Gys; Philip Plaeke; Bas Lamme; Thierry Lafullarde; Niels Komen; Anthony Beunis; Guy Hubens Journal: Obes Surg Date: 2019-09 Impact factor: 4.129
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Authors: Marvin Ryou; Kenneth R McQuaid; Christopher C Thompson; Steven Edmundowicz; Klaus Mergener Journal: Surg Endosc Date: 2017-11-14 Impact factor: 4.584
Authors: Marvin Ryou; Kenneth R McQuaid; Christopher C Thompson; Steven Edmundowicz; Klaus Mergener Journal: Obes Surg Date: 2018-01 Impact factor: 4.129
Authors: Marvin Ryou; Kenneth R McQuaid; Christopher C Thompson; Steven Edmundowic; Klaus Mergener Journal: J Gastrointest Surg Date: 2017-11-14 Impact factor: 3.452