Trials / Unknown
UnknownNCT01448785
Abiliti™ Treatment in Obese Subjects
Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- Sponsor
- IntraPace, Inc · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.
Detailed description
This study is intended to provide additional data regarding the performance and safety of the abiliti system in comparison to gastric banding. The composite end-point of the study is designed to provide a direct comparison of the effectiveness of the devices for the treatment of obesity while giving consideration to the safety profile for each device and their impact on patient quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | abiliti system implant | Subjects will receive implanted abiliti System. |
| DEVICE | Laparoscopic adjustable gastric band (Allergan Lap Band) | Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion. |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-01-01
- Completion
- 2015-01-01
- First posted
- 2011-10-07
- Last updated
- 2011-10-31
Locations
15 sites across 6 countries: France, Germany, Italy, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01448785. Inclusion in this directory is not an endorsement.