Skip to main content
OpenTrials
Completed

NCT Number: NCT00501085

LAP-BAND AP Early Experience Trial (APEX)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Apollo Endosurgery

Austin, Texas, 78746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LAP-BAND AP Adjustable Gastric Banding System

Device

Reduction of food intake due to creation of smaller stomach pouch.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Apollo Endosurgery, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2007
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.