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LAP-BAND AP Early Experience Trial (APEX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501085
First Posted: July 13, 2007
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.
  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

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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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).

  • 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).


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 11, 2007
First Posted: July 13, 2007
Results First Submitted: January 8, 2015
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015
Last Verified: January 2015

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


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