Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents

NCT00447590 | Completed Results

• 1 other identifier: LBA-001
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.

  Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.

  1 year

Secondary Outcomes (5)

• Subject Excess Weight Loss Throughout the Study

  Baseline to 5 Years

• Subject Percent Excess BMI Loss

  Baseline to 5 Years

• Change in Subjects' Comorbid Conditions

  Baseline to 5 Years

• Change in Quality of Life Using the Beck Depression Inventory II (BDI)

  Baseline to 5 Years

• Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire

  Baseline to 5 Years

Study Arms (1)

LAP-BAND

EXPERIMENTAL

All subjects who received the LAP-BAND System.

Device: LAP-BAND System

Interventions

LAP-BAND System DEVICE

Restriction of food intake

LAP-BAND

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 14 and 17 at the time of enrollment
• Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid 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:

• Family or 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

Sponsors & Collaborators

• Apollo Endosurgery, Inc.: lead

Study Sites (1)

Apollo Endosurgery

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Eaton, R.N., BSN, CCRN-R
• Organization: Apollo Endosurgery

laura.eaton@apolloendo.com

949-468-9301

Study Officials

• Apollo Endosurgery

  Apollo Endosurgery, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2013
• Last Updated: October 2, 2014
• Results First Posted: September 23, 2014

Record last verified: 2014-09

Locations

US (1)