Shelby Sullivan1, James Swain2, George Woodman3, Steven Edmundowicz4, Tarek Hassanein5, Vafa Shayani6, John C Fang7, Mark Noar8, George Eid9, Wayne J English10, Nabil Tariq11, Michael Larsen12, Sreenivasa S Jonnalagadda13, Dennis S Riff14, Jaime Ponce15, Dayna Early16, Eric Volckmann7, Anna R Ibele7, Matthew D Spann10, Kumar Krishnan11, Juan Carlos Bucobo17, Aurora Pryor17. 1. Washington University School of Medicine, St. Louis, Missouri; University of Colorado School of Medicine, Aurora, Colorado. Electronic address: shelby.sullivan@ucdenver.edu. 2. HonorHealth Research Institute, Scottsdale, Arizona. 3. Midsouth Bariatrics, Memphis, Tennessee. 4. Washington University School of Medicine, St. Louis, Missouri; University of Colorado School of Medicine, Aurora, Colorado. 5. Southern California Research Center, Coronado, California. 6. Bariatric Institute of Greater Chicago, Bolingbrook, Illinois. 7. University of Utah Hospital, Salt Lake City, Utah. 8. Endoscopy Microsurgery Associates, Townson, Maryland. 9. Alleghany Singer Research at West Penn, Pittsburgh, Pennsylvania. 10. Vanderbilt University, Nashville, Tennessee. 11. Houston Methodist Research Institute, Houston, Texas. 12. Virginia Mason Medical Center, Seattle, Washington. 13. Saint Luke's Hospital of Kansas City, Kansas City, Missouri. 14. Anaheim Clinical Trials, Anaheim, California. 15. Chattanooga Bariatrics, Chattanooga, Tennessee. 16. Washington University School of Medicine, St. Louis, Missouri. 17. Stony Brook Medicine, Stony Brook, New York.
Abstract
BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING:Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS:Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.
RCT Entities:
BACKGROUND:Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.
Authors: Saurabh Chandan; Babu P Mohan; Shahab R Khan; Antonio Facciorusso; Daryl Ramai; Lena L Kassab; Neil Bhogal; Ravishankar Asokkumar; Gortrand Lopez-Nava; Stephanie McDonough; Douglas G Adler Journal: Obes Surg Date: 2021-01-06 Impact factor: 4.129
Authors: Eric J Vargas; Fateh Bazerbachi; Andrew C Storm; Monika Rizk; Andres Acosta; Karen Grothe; Matt M Clark; Manpreet S Mundi; Carl M Pesta; Ahmad Bali; Eric Ibegbu; Rachel L Moore; Vivek Kumbhari; Trace Curry; Reem Z Sharaiha; Barham K Abu Dayyeh Journal: Obes Surg Date: 2019-12 Impact factor: 4.129
Authors: Eric J Vargas; Fateh Bazerbachi; Gerardo Calderon; Larry J Prokop; Victoria Gomez; M Hassan Murad; Andres Acosta; Michael Camilleri; Barham K Abu Dayyeh Journal: Clin Gastroenterol Hepatol Date: 2019-04-04 Impact factor: 11.382
Authors: Andrea Telese; Vinay Sehgal; Cormac G Magee; S Naik; S A Alqahtani; L B Lovat; Rehan J Haidry Journal: Clin Transl Gastroenterol Date: 2021-06-18 Impact factor: 4.488