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

Apollo Endosurgery

Status

Completed

Conditions

Obesity

Treatments

Device: LAP-BAND System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00570505

LBMI-001

Details and patient eligibility

About

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.

Full description

LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.

Enrollment

151 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a BMI ≥ 30 kg/m2 and < 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and < 40 kg/m2 without severe comorbid conditions
Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion criteria

Subject history of congenital or acquired anomalies of the gastrointestinal tract
Severe cardiopulmonary or other serious or uncontrolled organic disease
Severe coagulopathy; hepatic insufficiency or cirrhosis
History of bariatric; gastric; or esophageal surgery
History of intestinal obstruction or adhesive peritonitis
History of esophageal dysmotility disorders
Type I diabetes