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HERO Study: Helping Evaluate Reduction in Obesity

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ClinicalTrials.gov Identifier: NCT00953173
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Device: LAP-BAND AP® Adjustable Gastric Banding System

Study Design

Study Type : Observational
Actual Enrollment : 1106 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2009
Primary Completion Date : July 2016
Study Completion Date : October 2016
Groups and Cohorts

Group/Cohort Intervention/treatment
LapBand
Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System
Device: LAP-BAND AP® Adjustable Gastric Banding System
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.
Other Name: LAP-BAND AP®


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Apollo Endosurgery, Inc.