N/A
N=149
Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00570505 ↗Enrolled (actual)
149
Serious AEs
12.1%
Results posted
Dec 2012
Primary outcome: Primary: Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation — 83.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LAP-BAND System (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Apollo Endosurgery, Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation |
83.9 | — |
| SECONDARY Percent Weight Loss |
18.32 | — |
| SECONDARY Change in Comorbid Conditions Related to Obesity |
33.3; 27.6; 22.2 | — |
| SECONDARY Change in Quality of Life |
28.03 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT00570505). 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.