Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band (SAGB-PM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00543140
First received: August 28, 2007
Last updated: February 9, 2016
Last verified: February 2016
Results First Received: January 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Morbid Obesity
Intervention: Device: REALIZE™ Swedish Adjustable Gastric Band

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
REALIZE™ Adjustable Gastric Band

All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.

Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band


Participant Flow:   Overall Study
    REALIZE™ Adjustable Gastric Band  
STARTED     303  
COMPLETED     231  
NOT COMPLETED     72  
Lost to Follow-up                 33  
Withdrawal by Subject                 13  
Protocol Violation                 10  
Insufficient weight loss                 10  
SAE leading to explant of SAGB                 3  
Death                 1  
Subject moved                 1  
Conversion to different procedure                 1  



  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.
All subjects implanted with the SAGB.

Reporting Groups
  Description
REALIZE™ Adjustable Gastric Band

All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.

Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band


Baseline Measures
    REALIZE™ Adjustable Gastric Band  
Number of Participants  
[units: participants]
  303  
Age  
[units: years]
Mean (Standard Deviation)
  40.5  (9.90)  
Gender  
[units: participants]
 
Female     242  
Male     61  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian, not of Hispanic origin     205  
Hispanic     55  
Black, not of Hispanic origin     27  
Asian/Pacific Islander     8  
Other     8  
Region of Enrollment  
[units: participants]
 
United States     303  
Weight (lbs)  
[units: pounds]
Mean (Standard Deviation)
  272.2  (40.78)  
Body Mass Index (kg/m^2)  
[units: kilograms per meters squared]
Mean (Standard Deviation)
  44.1  (4.76)  



  Outcome Measures
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1.  Primary:   Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.   [ Time Frame: 5 years ]

2.  Secondary:   Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.   [ Time Frame: 5 years ]

3.  Secondary:   Percent Change in Excess Body Weight at 5 Years Post-implant   [ Time Frame: 5 years ]

4.  Secondary:   Change in SF-36 Health Survey Physical Component at 5 Years Post Implant   [ Time Frame: 5 years ]

5.  Secondary:   Change in SF-36 Health Survey Mental Component at 5 Years Post Implant   [ Time Frame: 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Michael Schwiers, Principal Biostatistician
Organization: Ethicon Endo-Surgery
phone: 513-337-1172
e-mail: mschwier@its.jnj.com



Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00543140     History of Changes
Obsolete Identifiers: NCT00813462
Other Study ID Numbers: CI-06-0001/CI-07-0006
Study First Received: August 28, 2007
Results First Received: January 11, 2016
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration