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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: January 15, 2015
Last verified: January 2015

July 11, 2007
January 15, 2015
June 2007
August 2013   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00501085 on ClinicalTrials.gov Archive Site
  • 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).
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LAP-BAND AP Early Experience Trial (APEX)
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The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Community sample
Obesity, Morbid
Device: LAP-BAND AP Adjustable Gastric Banding System
Reduction of food intake due to creation of smaller stomach pouch.
LAP-BAND
Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
Intervention: Device: LAP-BAND AP Adjustable Gastric Banding System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
521
November 2013
August 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00501085
MedAff-LBAP201
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Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc.
Not Provided
Study Director: Apollo Endosurgery Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP