Trials / Completed
CompletedNCT00960843
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
A Randomized, Controlled, 6-month Study to Compare the Effects of Volume- and Pressure-guided Adjustments on Weight Loss and Satiety in Patients Implanted With the Swedish Adjustable Gastric Band
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intraband pressure recording system | Intraband pressure will be measured by a pressure recording system. |
| OTHER | Conventional Adjustment | Band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2009-08-18
- Last updated
- 2012-08-20
- Results posted
- 2012-04-03
Locations
2 sites across 2 countries: Australia, Czechia
Source: ClinicalTrials.gov record NCT00960843. Inclusion in this directory is not an endorsement.