Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 1, 2021

Primary Completion Date

May 30, 2022

Study Completion Date

May 30, 2022

Conditions
ObesityNASH - Nonalcoholic SteatohepatitisObesity, Morbid
Interventions
DEVICE

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

BEHAVIORAL

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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ReShape Lifesciences

INDUSTRY

lead

Johns Hopkins University

OTHER