LAP-BAND AP Early Experience Trial (APEX)

Obesity, Morbid Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501085
• Other study ID #: MedAff-LBAP201
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: January 15, 2015
• Start date: June 2007
• Est. completion date: November 2013

Study information

• 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

Clinical Trial Summary

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

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.

Recruitment information / eligibility

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Device:
• LAP-BAND AP Adjustable Gastric Banding System
Reduction of food intake due to creation of smaller stomach pouch.

Locations

Country	Name	City	State
United States	Apollo Endosurgery	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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