LAP-BAND AP Early Experience Trial (APEX)
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
- Percent Excess Weight Loss (%EWL) [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]Subjects' Percent Excess Weight Loss (%EWL) over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
- Change in BMI [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]The change in subjects' Body Mass Index (BMI) was examined at 5 years post LAP-BAND placement.
- Change in Satiety [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
- Change in Quality of Life [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17) .
- Subject Reported Sleepiness (Epworth Sleepiness Scale) [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. The questionnaire presents eight situations for subjects to score their level of sleepiness, using a scale from 0 (would never doze or sleep) to 3 (high chance of dozing or sleeping).
|Study Start Date:||June 2007|
|Study Completion Date:||November 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
Device: LAP-BAND AP Adjustable Gastric Banding System
Reduction of food intake due to creation of smaller stomach pouch.
The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501085
|United States, Texas|
|Austin, Texas, United States, 78746|
|Study Director:||Apollo Endosurgery||Apollo Endosurgery, Inc.|