N/A
Completed N=153
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Source: ClinicalTrials.gov NCT00447590 ↗Enrolled (actual)
153
Serious AEs
13.1%
Results posted
Sep 2014
Primary outcomePrimary: Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. — 49.7 percentage of participants — p=<0.0001
Summary
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. |
49.7 | <0.0001 sig |
| SECONDARY Subject Excess Weight Loss Throughout the Study |
27.0 | — |
| SECONDARY Subject Percent Excess BMI Loss |
-6.0 | — |
| SECONDARY Change in Subjects' Comorbid Conditions |
3; 14; 7 | — |
| SECONDARY Change in Quality of Life Using the Beck Depression Inventory II (BDI) |
-1.0 | — |
| SECONDARY Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire |
18.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00447590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.