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.
Call for more information