Trial record 1 of 1 for:    NCT00570505
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Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00570505
First received: December 10, 2007
Last updated: January 9, 2014
Last verified: January 2014
  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:


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
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Publications:
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: January 9, 2014
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 April 23, 2014