LAP-BAND AP Early Experience Trial (APEX)
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|ClinicalTrials.gov Identifier: NCT00501085|
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
|Condition or disease||Intervention/treatment|
|Obesity, Morbid||Device: LAP-BAND AP Adjustable Gastric Banding System|
|Study Type :||Observational|
|Actual Enrollment :||521 participants|
|Study Start Date :||June 2007|
|Primary Completion Date :||August 2013|
|Study Completion Date :||November 2013|
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.
- Change in Percent Excess Weight [ Time Frame: Baseline to 5 Years ]Subjects' Percent Excess Weight Loss (%EWL) from baseline 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.
- Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation [ Time Frame: Baseline to 5 years ]Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
- Subject Reported Satiety [ Time Frame: Baseline to 5 Years ]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.
- Subject Reported Quality of Life [ Time Frame: Baseline to 5 Years ]Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
- Subject Reported Sleepiness (Epworth Sleepiness Scale) [ Time Frame: Baseline to 5 years ]The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501085
|United States, Texas|
|Austin, Texas, United States, 78746|
|Study Director:||Apollo Endosurgery||Apollo Endosurgery, Inc.|