LAP-BAND AP Early Experience Trial (APEX)

Completed

• Conditions: Obesity, Morbid
• Interventions: Device: LAP-BAND AP Adjustable Gastric Banding System

• Registration Number: NCT00501085
• Lead Sponsor: Apollo Endosurgery, Inc.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2015-01
• Results First Submitted: 2015-01-08
• Results First Submitted QC: 2015-01-15
• Last Update Submitted: 2015-01-15
• Results First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 521

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAP-BAND	LAP-BAND AP Adjustable Gastric Banding System	Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.

Primary Outcome Measures

Name	Time	Method
Change in Percent Excess Weight	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.

Secondary Outcome Measures

Name	Time	Method
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation	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	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	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)	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).

Trial Locations

Locations (1)

Apollo Endosurgery; 🇺🇸 Austin, Texas, United States