N/A
Completed N=671
HERO Study: Helping Evaluate Reduction in Obesity
Source: ClinicalTrials.gov NCT00953173 ↗Enrolled (actual)
671
Serious AEs
16.3%
Results posted
Feb 2018
Primary outcomePrimary: %TBWL — -18.0 % TBWL
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 Banding System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY %TBWL |
-18.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00953173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.