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

This study is ongoing, but not recruiting participants.

Sponsored by:	Allergan Medical
Information provided by:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00570505

Purpose

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.

Condition	Intervention
Obesity	Device: LAP-BAND System

MedlinePlus related topics: Obesity Weight Control

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment

Further study details as provided by Allergan Medical:

Primary Outcome Measures:

Percent of subjects who attain clinically successful weight loss of ≥30% EWL at one year post LAP-BAND implantation. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% EWL, changes in: BMI, weight(pounds), comorbid conditions related to obesity, quality of life,depression symptom and severity scores ; maintenance of weight loss >1 year, % of subjects who attain ≥ 30% EWL at timepoints other than one year. [ Time Frame: One year or greater ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Reduction of food intake due to creation of smaller stomach pouch

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570505

Locations

United States, Washington

Seattle, Washington, United States

Sponsors and Collaborators

Allergan Medical

More Information

Responsible Party:	Allergan ( Allergan Medical )
Study ID Numbers:	LBMI-001
Study First Received:	December 10, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00570505
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 13, 2009