LAP-BAND AP Early Experience Trial (APEX)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Detailed Description
-----------------
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.

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Device: LAP-BAND AP Adjustable Gastric Banding System


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAP-BAND<br>Patients who receive the LAP-BAND AP Adjustable Gastric Banding System. | Device: LAP-BAND AP Adjustable Gastric Banding System<br>* Reduction of food intake due to creation of smaller stomach pouch.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |