Overview

This trial is active, not recruiting.

Condition obesity
Treatment lap-band ap® adjustable gastric banding system
Sponsor Apollo Endosurgery, Inc.
Start date December 2009
End date July 2016
Trial size 1106 participants
Trial identifier NCT00953173, HERO Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System
lap-band ap® adjustable gastric banding system LAP-BAND AP®
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.

Primary Outcomes

Measure
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

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Apollo Endosurgery, Inc..