HERO Study: Helping Evaluate Reduction in Obesity
This trial is active, not recruiting.
|Treatment||lap-band ap® adjustable gastric banding system|
|Sponsor||Apollo Endosurgery, Inc.|
|Start date||December 2009|
|End date||July 2016|
|Trial size||1106 participants|
|Trial identifier||NCT00953173, HERO Study|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Everett, WA||not available||no longer recruiting|
|Adelaide, Australia||not available||no longer recruiting|
|Jette, Belgium||not available||no longer recruiting|
|Mississauga, Canada||not available||no longer recruiting|
|Naples, Italy||not available||no longer recruiting|
|Birmingham, United Kingdom||not available||no longer recruiting|
Change in weight, waist and hip circumference, blood pressure, HbA1c, fasting glucose, lipid profile, concomitant medications, and health-related quality of life (HRQOL)
time frame: 5 years
Male or female participants at least 18 years old.
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.
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