LAP-BAND AP Early Experience Trial (APEX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00501085
First received: July 11, 2007
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Excess Weight Loss (%EWL) [ Time Frame: Baseline to 5 Years ] [ Designated as safety issue: No ]
    Subjects' Percent Excess Weight Loss (%EWL) 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:
  • Change in BMI [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
    The change in subjects' Body Mass Index (BMI) was examined at 5 years post LAP-BAND placement.

  • Change in 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.

  • Change in 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) .

  • 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. The questionnaire presents eight situations for subjects to score their level of sleepiness, using a scale from 0 (would never doze or sleep) to 3 (high chance of dozing or sleeping).


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
LAP-BAND
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.

  Eligibility

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

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)
  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 ClinicalTrials.gov identifier: NCT00501085

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

No publications provided by Apollo Endosurgery, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00501085     History of Changes
Other Study ID Numbers: MedAff-LBAP201
Study First Received: July 11, 2007
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014