HERO Study: Helping Evaluate Reduction in Obesity

Completed

• Conditions: Obesity
• Interventions: Device: LAP-BAND AP® Adjustable Gastric Banding System

• Registration Number: NCT00953173
• Lead Sponsor: Apollo Endosurgery, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2009-12
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Results First Submitted: 2017-08-07
• Results First Submitted QC: 2017-08-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Results First Posted: 2018-02-09
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
%TBWL	5 years	Percent of total body weight change.