HERO Study: Helping Evaluate Reduction in Obesity

Apollo Endosurgery

Status: Completed

Conditions: Obesity

Treatments: Device: LAP-BAND AP® Adjustable Gastric Banding System

Study type: Observational

Funder types: Industry

Identifiers

NCT00953173

HERO Study

Details and patient eligibility

About

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.

Enrollment: 671 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

671 participants in 1 patient group

LapBand

Description:

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

Treatment:

Device: LAP-BAND AP® Adjustable Gastric Banding System