HERO Study: Helping Evaluate Reduction in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00953173
First received: August 5, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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 10, 2013
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 April 17, 2014