Start Date
March 1, 2021
Primary Completion Date
May 30, 2022
Study Completion Date
May 30, 2022
Intragastric balloon
Intragastric balloon insertion will be performed by an endoscopist under monitored anesthesia care. The Intragastric BalIoon (GB) comes as a deflated balloon pre-loaded on a catheter, which is inserted transorally into the proximal gastric body. An endoscope is then inserted alongside the device allowing for direct visualization of the balloon. Once in place, the intragastric balloon will be filled with saline through an external port. The balloon is inserted for 6 months then retrieved endoscopically
Lifestyle intervention
All patients included in the study will undergo an evaluation by a nutritionist. All participants will receive recommendations for a diet. Participants will be instructed to keep a daily food diary and will meet with the nutritionist to reinforce the behavior every 12 weeks for 12 months.
Collaborators (1)
ReShape Lifesciences
INDUSTRY
Johns Hopkins University
OTHER