Status:
COMPLETED
HERO Study: Helping Evaluate Reduction in Obesity
Lead Sponsor:
Apollo Endosurgery, Inc.
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
671 Patients enrolled
Trial Details
Trial ID
NCT00953173
Start Date
December 1 2009
End Date
October 1 2016
Last Update
March 8 2018
Active Locations (6)
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1
Everett, Washington, United States
2
Adelaide, South Australia, Australia
3
Jette, Belgium
4
Mississauga, Ontario, Canada