Obesity, Morbid Clinical Trial
Verified date | January 2015 |
Source | Apollo Endosurgery, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
Status | Completed |
Enrollment | 521 |
Est. completion date | November 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is scheduled to receive the LAP-BAND AP System - Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires. Exclusion Criteria: - Per the LAP-BAND AP System Directions For Use (DFU) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Apollo Endosurgery | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Apollo Endosurgery, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Percent Excess Weight | 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. | Baseline to 5 Years | No |
Secondary | Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation | Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation. | Baseline to 5 years | No |
Secondary | Subject Reported Satiety | 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. | Baseline to 5 Years | No |
Secondary | Subject Reported Quality of Life | 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). | Baseline to 5 Years | No |
Secondary | Subject Reported Sleepiness (Epworth Sleepiness Scale) | 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). | Baseline to 5 years | No |
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