HERO Study: Helping Evaluate Reduction in Obesity
Completed
Conditions studied: Obesity
In brief
A prospective, international, multi-center study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND AP® Adjustable Gastric Banding System.
Key facts
- Study ID
- NCT00953173
- Run by
- Apollo Endosurgery, Inc.
- People needed
- 671
- Starts
- 2009-12-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2018-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient and investigator have made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
- Male or female aged ≥ 18 years.
- BMI ≥ 40 or a BMI ≥ 35 with one or more severe co-morbid conditions, or those who are 45.5 Kg / 100 lbs or more over their estimated ideal weight.
You may not qualify if…
- Prior bariatric surgery.
- Type I diabetes patients.
- Participating in another ongoing clinical study with concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
Where it is running
- Study site — Everett, Washington, United States
- Study site — Adelaide, South Australia, Australia
- Study site — Jette, Belgium
- Study site — Mississauga, Ontario, Canada
- Study site — Naples, Italy
- Study site — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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