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NCT00730327 · ClinicalTrials.gov registry record · NA
A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
A NA study, sponsored by Apollo Endosurgery.
- Completed
- Registry status
- NA
- Development phase
- 448
- Enrollment target
NCT00730327: Completed NA study, sponsored by Apollo Endosurgery.
NCT00730327 is a NA study that has completed, run by Apollo Endosurgery. The registered enrollment target is 448 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00730327, a NA study, has completed, sponsored by Apollo Endosurgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 448 participants
- Enrollment target
Study Summary
Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.
Primary Outcome
The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight -
Interventions
- DEVICE BioEnterics® Intragastric Balloon
- OTHER Behavioral modification
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 448 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT00730327 record still lists
NCT00730327 is an interventional study that assigns participants to a tested intervention. The registered 448 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which BioEnterics® Intragastric Balloon is the first listed.
NCT00730327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00730327 about?
NCT00730327 is a clinical study titled "A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects". Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.
What is the current status of trial NCT00730327?
This trial is currently completed. It is a NA study. The enrollment target is 448 participants. The study started on 2008-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00730327?
The interventions under investigation include: BioEnterics® Intragastric Balloon (DEVICE), Behavioral modification (OTHER).
Who is sponsoring clinical trial NCT00730327?
This trial is sponsored by Apollo Endosurgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00730327's enrollment target sits among peer trials
448 233rd of 2000 higher than 1,768 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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