LAP-BAND AP Early Experience Trial (APEX)

This study has been completed.
Information provided by (Responsible Party):
Apollo Endosurgery, Inc. Identifier:
First received: July 11, 2007
Last updated: January 15, 2015
Last verified: January 2015
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Condition Intervention
Obesity, Morbid
Device: LAP-BAND AP Adjustable Gastric Banding System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Apollo Endosurgery, Inc.:

Primary Outcome Measures:
  • Change in Percent Excess Weight [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]
    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:
  • Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
    Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.

  • Subject Reported Satiety [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
    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).

Enrollment: 521
Study Start Date: June 2007
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
Device: LAP-BAND AP Adjustable Gastric Banding System
Reduction of food intake due to creation of smaller stomach pouch.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00501085

United States, Texas
Apollo Endosurgery
Austin, Texas, United States, 78746
Sponsors and Collaborators
Apollo Endosurgery, Inc.
Study Director: Apollo Endosurgery Apollo Endosurgery, Inc.
  More Information

No publications provided by Apollo Endosurgery, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Apollo Endosurgery, Inc. Identifier: NCT00501085     History of Changes
Other Study ID Numbers: MedAff-LBAP201
Study First Received: July 11, 2007
Results First Received: January 8, 2015
Last Updated: January 15, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity, Morbid
Body Weight
Nutrition Disorders
Signs and Symptoms processed this record on November 27, 2015