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Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC) (NRC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01216319
First received: October 5, 2010
Last updated: May 19, 2016
Last verified: May 2016
Results First Received: April 30, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Reconstruction
Nipple Reconstruction
Intervention: Device: Nipple reconstruction

  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
Nipple Reconstruction Cylinder Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder

Participant Flow:   Overall Study
    Nipple Reconstruction Cylinder
STARTED   50 
COMPLETED   46 
NOT COMPLETED   4 
Lost to Follow-up                2 
Unanticipated chemo for breast cancer                2 



  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
Nipple Reconstruction Cylinder Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder

Baseline Measures
   Nipple Reconstruction Cylinder 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (8.7) 
Gender 
[Units: Participants]
 
Female   50 
Male   0 


  Outcome Measures
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1.  Primary:   Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)   [ Time Frame: 12 months ]

2.  Secondary:   Rate of Patient Satisfaction   [ Time Frame: 12 months ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jason Hodde, Clinical Affairs Manager
Organization: Cook Biotech Incorporated
phone: 765-497-3355
e-mail: jhodde@cookbiotech.com



Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01216319     History of Changes
Other Study ID Numbers: 09-009
Study First Received: October 5, 2010
Results First Received: April 30, 2015
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board