HERO Study: Helping Evaluate Reduction in Obesity
This study is ongoing, but not recruiting participants.
Sponsor:
Allergan Medical
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00953173
First received: August 5, 2009
Last updated: December 7, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Device: LAP-BAND AP® Adjustable Gastric Banding System (LAP-BAND AP®) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Allergan Medical:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 1106 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | March 2016 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
LapBand
Patients who have already consented to receive the LAP-BAND AP®
|
Device: LAP-BAND AP® Adjustable Gastric Banding System (LAP-BAND AP®)
The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients that have already made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953173
Locations
| United States, Washington | |
| Everett, Washington, United States | |
| Australia, South Australia | |
| Adelaide, South Australia, Australia | |
| Belgium | |
| Jette, Belgium | |
| Canada, Ontario | |
| Mississauga, Ontario, Canada | |
| Italy | |
| Naples, Italy | |
| United Kingdom | |
| Birmingham, United Kingdom | |
Sponsors and Collaborators
Allergan Medical
More Information
No publications provided
| Responsible Party: | Allergan Medical |
| ClinicalTrials.gov Identifier: | NCT00953173 History of Changes |
| Other Study ID Numbers: | HERO Study |
| Study First Received: | August 5, 2009 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013