A Courcoulas1, B K Abu Dayyeh2, L Eaton3, J Robinson4, G Woodman5, M Fusco6, V Shayani7, H Billy8, D Pambianco9, C Gostout2,10. 1. Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. 2. Mayo Clinic, Rochester, MN, USA. 3. UltaMed Corporation, Huntington Beach, CA, USA. 4. Simulstat Incorporated, San Diego, CA, USA. 5. George Woodman, MD, PC, Memphis, TN, USA. 6. Health First Medical Group, Melbourne, FL, USA. 7. St James Hospital, Olympia Fields, IL, USA. 8. Ventura Advanced Surgical Associates, Ventura, CA, USA. 9. Charlottesville Medical Research, Charlottesville, VA, USA. 10. Apollo Endosurgery, Austin, TX, USA.
Abstract
BACKGROUND/ OBJECTIVES: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention. SUBJECTS/ METHODS: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m-2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss. RESULTS: At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P⩽0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found. CONCLUSIONS AND RELEVANCE: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
RCT Entities:
BACKGROUND/ OBJECTIVES: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention. SUBJECTS/ METHODS: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m-2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss. RESULTS: At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P⩽0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found. CONCLUSIONS AND RELEVANCE: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
Authors: Alia Hadefi; Marianna Arvanitakis; Vincent Huberty; Jacques Devière Journal: United European Gastroenterol J Date: 2020-07 Impact factor: 4.623
Authors: Eric J Vargas; Carl M Pesta; Ahmad Bali; Eric Ibegbu; Fateh Bazerbachi; Rachel L Moore; Vivek Kumbhari; Reem Z Sharaiha; Trace W Curry; Gina DosSantos; Ramsey Schmitz; Abhishek Agnihotri; Aleksey A Novikov; Tracy Pitt; Margo K Dunlap; Andrea Herr; Louis Aronne; Erin Ledonne; Hoda C Kadouh; Lawrence J Cheskin; Manpreet S Mundi; Andres Acosta; Christopher J Gostout; Barham K Abu Dayyeh Journal: Clin Gastroenterol Hepatol Date: 2018-02-07 Impact factor: 11.382
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