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
Results First Received: January 8, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Obesity, Morbid
Intervention: Device: LAP-BAND AP Adjustable Gastric Banding System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
521 Subjects were enrolled (defined as signing the informed consent). 515 Subjects started treatment and underwent LAP-BAND implantation. 6 Subjects did not have the LAP-BAND implanted after enrolling and signing the informed consent.

Reporting Groups
  Description
LAP-BAND

Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.

LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch.


Participant Flow:   Overall Study
    LAP-BAND  
STARTED     515 [1]
COMPLETED     83 [2]
NOT COMPLETED     432  
Lost to Follow-up                 195  
Withdrawal by Subject                 34  
Subject Decision                 1  
Revision Surgery                 7  
Explantation Surgery                 26  
Adverse Event                 4  
Non-Compliance                 24  
Study closed by sponsor                 109  
Other loss to follow-up                 32  
[1] Number of participants who were treated with the LAP-BAND System.
[2] Number of participants completing 5 year follow-up visit.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population is defined as the number of subjects who underwent treatment with the LAP-BAND System.

Reporting Groups
  Description
LAP-BAND

Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.

LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch.


Baseline Measures
    LAP-BAND  
Number of Participants  
[units: participants]
  515  
Age  
[units: years]
Mean (Standard Deviation)
  42.7  (10.89)  
Age, Customized  
[units: years]
Median (Full Range)
 
Median Age     42.7  
  (18.5 to 70.6)  
Gender  
[units: participants]
 
Female     422  
Male     93  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     0  
Black     52  
Hispanic     16  
Caucasian     443  
Other (Native American or unspecified)     3  
Missing     1  
Baseline Weight  
[units: pounds (lbs)]
Mean (Standard Deviation)
  273.9  (51.37)  
Body Mass Index (BMI) at Baseline  
[units: kg/m2]
Mean (Standard Deviation)
  44.0  (6.25)  
Baseline Excess Weight [1]
[units: pounds (lbs)]
Mean (Standard Deviation)
  118.7  (42.46)  
[1] Excess weight is equal to subject weight minus ideal weight (ideal weight is based on having a BMI of 25)



  Outcome Measures
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1.  Primary:   Change in Percent Excess Weight   [ Time Frame: Baseline to 5 Years ]

2.  Secondary:   Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation   [ Time Frame: Baseline to 5 years ]

3.  Secondary:   Subject Reported Satiety   [ Time Frame: Baseline to 5 Years ]

4.  Secondary:   Subject Reported Quality of Life   [ Time Frame: Baseline to 5 Years ]

5.  Secondary:   Subject Reported Sleepiness (Epworth Sleepiness Scale)   [ Time Frame: Baseline to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Laura Eaton, R.N., BSN, CCRN-R
Organization: Apollo Endosurgery, Inc.
phone: 949-468-9301
e-mail: laura.eaton@apolloendo.com


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
Results First Received: January 8, 2015
Last Updated: January 15, 2015
Health Authority: United States: Institutional Review Board