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

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00570505

Run by

Apollo Endosurgery, Inc.

People needed

151

Starts

2007-11-01

Expected to finish

2013-11-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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