HERO Study: Helping Evaluate Reduction in Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adelaide, South Australia, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LAP-BAND AP® Adjustable Gastric Banding System

Device

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 names: LAP-BAND AP®

Primary outcomes

%TBWL

Time frame: 5 years

Percent of total body weight change.

Sponsors and collaborators

Lead sponsor

Apollo Endosurgery, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Aug 6, 2009
Registry last updated: Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed