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European Union (EU) Post-Market Study on Easyband®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00948246
First received: July 28, 2009
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
Results First Received: June 27, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Morbid Obesity
Intervention: Device: Easyband®

  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
Easyband No text entered.

Participant Flow:   Overall Study
    Easyband  
STARTED     110  
COMPLETED     86  
NOT COMPLETED     24  
Lost to Follow-up                 11  
Adverse Event                 11  
Death                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Easyband No text entered.

Baseline Measures
    Easyband  
Number of Participants  
[units: participants]
 		  110  
Age  
[units: participants]
 		 
<=18 years     3  
Between 18 and 65 years     107  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  39.0  ± 11.23  
Gender  
[units: participants]
 		 
Female     84  
Male     26  
Region of Enrollment  
[units: participants]
 		 
Belgium     33  
Netherlands     29  
Italy     21  
United Kingdom     27  



  Outcome Measures
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1.  Primary:   Feasibility and Ease of Implantation   [ Time Frame: < 1day ]
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2.  Secondary:   % Excess Weight Loss   [ Time Frame: 12 months ]
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3.  Secondary:   Change in BMI   [ Time Frame: 12 months ]
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4.  Secondary:   Change in Weight   [ Time Frame: 12 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Medical Monitor
Organization: Allergan Medical
phone: (805) 961-5000
e-mail: devicetrials@allergan.com


No publications provided


Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00948246     History of Changes
Other Study ID Numbers: CIP10088
Study First Received: July 28, 2009
Results First Received: June 27, 2012
Last Updated: October 26, 2012
Health Authority: Belgium: C.U.B. Hôpital Erasme - ULB
Netherlands: St Antonius Ziekenhuis Secretariaat LTME