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

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ClinicalTrials.gov Identifier: NCT01216319
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : May 15, 2015
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Breast Reconstruction
Nipple Reconstruction
Intervention Device: Nipple reconstruction
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nipple Reconstruction Cylinder
Hide Arm/Group Description Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Period Title: Overall Study
Started 50
Completed 46
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
Unanticipated chemo for breast cancer             2
Arm/Group Title Nipple Reconstruction Cylinder
Hide Arm/Group Description Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
52  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
50
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were two patients (three nipples) without plastic surgery matrix in place at 12MO.
Arm/Group Title Nipple Reconstruction Cylinder
Hide Arm/Group Description:
Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Overall Number of Participants Analyzed 44
Overall Number of Units Analyzed
Type of Units Analyzed: Nipples
72
Mean (Standard Deviation)
Unit of Measure: percentage of projection vs baseline
37.3  (17.5)
2.Secondary Outcome
Title Rate of Patient Satisfaction
Hide Description Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nipple Reconstruction Cylinder
Hide Arm/Group Description:
Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of patients
97.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nipple Reconstruction Cylinder
Hide Arm/Group Description Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
All-Cause Mortality
Nipple Reconstruction Cylinder
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nipple Reconstruction Cylinder
Affected / at Risk (%) # Events
Total   1/50 (2.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic breast cancer   1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nipple Reconstruction Cylinder
Affected / at Risk (%) # Events
Total   3/50 (6.00%)    
Surgical and medical procedures   
Cylinder extrusion   3/50 (6.00%)  4
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Hodde, Clinical Affairs Manager
Organization: Cook Biotech Incorporated
Phone: 765-497-3355
EMail: jhodde@cookbiotech.com
Layout table for additonal information
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01216319     History of Changes
Other Study ID Numbers: 09-009
First Submitted: October 5, 2010
First Posted: October 7, 2010
Results First Submitted: April 30, 2015
Results First Posted: May 15, 2015
Last Update Posted: June 23, 2016