HERO Study: Helping Evaluate Reduction in Obesity
Completed
- Conditions
- Obesity
- Registration Number
- NCT00953173
- Lead Sponsor
- Apollo Endosurgery, Inc.
- 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 Banding System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 671
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method %TBWL 5 years Percent of total body weight change.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term efficacy outcomes of LAP-BAND AP® adjustable gastric banding in the HERO study for obesity management?
How does the LAP-BAND AP® system compare to bariatric surgery alternatives like Roux-en-Y gastric bypass in terms of healthcare resource utilization for obesity treatment?
What biomarkers are associated with successful weight loss outcomes following LAP-BAND AP® implantation in the HERO observational study?
What adverse events were reported in the HERO study for LAP-BAND AP® and how do they compare to other endoscopic obesity interventions?
How does the HERO study's data on LAP-BAND AP® contribute to the understanding of metabolic changes and obesity-related comorbidities in bariatric patients?