Trials / Completed
CompletedNCT01444274
Pilot Study to Evaluate A Novel Gastric Space Occupying Device
A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Obalon Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obalon Gastric Balloon(s) | One or two balloons administered per patient |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2011-09-30
- Last updated
- 2019-03-15
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT01444274. Inclusion in this directory is not an endorsement.