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.

Sponsor:

Information provided by (Responsible Party):

Allergan Medical

ClinicalTrials.gov Identifier:

NCT00570505

First received: December 10, 2007

Last updated: December 17, 2012

Last verified: December 2012

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:

Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. Percent EWL Was Defined as Weight Loss Divided by Excess Weight Multiplied by 100. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% Weight Loss [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.
Change in Comorbid Conditions Related to Obesity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation.
Change in Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline score on the IWQOL-Lite Total Score, where 0 is worst and 100 is best.

Enrollment:	151
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2013
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LapBand	Device: LAP-BAND System 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

No publications provided

Responsible Party:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00570505 History of Changes
Other Study ID Numbers:	LBMI-001
Study First Received:	December 10, 2007
Results First Received:	July 23, 2012
Last Updated:	December 17, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013