HERO Study: Helping Evaluate Reduction in Obesity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

NCT02356614

Obesity Overweight

TERMINATED

LAP-BAND AP Early Experience Trial (APEX)

NCT00501085

Obesity, Morbid

COMPLETED

Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2

NCT00570505

Obesity

COMPLETED NA

Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents

NCT00447590

Morbid Obesity

COMPLETED NA

Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

NCT01149512

Morbid Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LapBand

Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System

LAP-BAND AP® Adjustable Gastric Banding System

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LAP-BAND AP®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No