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):
Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00570505
First received: December 10, 2007
Last updated: August 15, 2014
Last verified: August 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 Apollo Endosurgery, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Apollo Endosurgery, Inc.
  More Information

Publications:
Responsible Party: Apollo Endosurgery, Inc.
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: August 15, 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 August 21, 2014