NCT03530410

Gastric and Autonomic Functions in Patients With Intragastric Balloon

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function

Detailed description

The intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. Additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. The exact mechanism of function, however, is not clear and likely multifactorial. The investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.

Conditions

• Obesity
• Obesity, Morbid

Interventions

Type	Name	Description
DEVICE	Intragastric balloon placement	Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2018-05-21
• Last updated: 2021-03-30

Regulatory

• FDA-regulated device study