Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00691327
First received: June 3, 2008
Last updated: December 30, 2013
Last verified: December 2013
Results First Received: December 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Breast Reconstruction
Intervention: Device: Natrelle(TM) Silicone-Filled Breast Implants

  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
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Reporting Groups
  Description
Reconstruction Women who have undergone Breast Reconstruction
Revision Women who have undergone Revision of a Breast Augmentation or Reconstruction

Participant Flow:   Overall Study
    Reconstruction     Revision  
STARTED     45055     39274  
COMPLETED     42214     36766  
NOT COMPLETED     2841     2508  



  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.
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Reporting Groups
  Description
Reconstruction Women who have undergone Breast Reconstruction
Revision Women who have undergone Revision of a Breast Augmentation or Reconstruction
Total Total of all reporting groups

Baseline Measures
    Reconstruction     Revision     Total  
Number of Participants  
[units: participants]
  45055     39274     84329  
Age, Customized  
[units: participants]
     
<=17 years     115     4     119  
Between 18 and 69 years     43304     37612     80916  
>=70 years     1065     1039     2104  
Not provided     571     619     1190  
Gender  
[units: participants]
     
Female     45055     39274     84329  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Local Complications   [ Time Frame: 5 years ]

2.  Secondary:   Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  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, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00691327     History of Changes
Other Study ID Numbers: 910044
Study First Received: June 3, 2008
Results First Received: December 30, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board