Status:
COMPLETED
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Mentor Worldwide, LLC
Conditions:
Contour Irregularity of Reconstructed Breast
Eligibility:
FEMALE
25-85 years
Phase:
NA
Brief Summary
The purpose of this study is to explore the volume change and location of volume change in reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to investigate the safe...
Detailed Description
Tissue expansion is an accepted and widely used method for breast reconstruction. A drawback in using standard tissue expanders is unwanted fullness at the upper pole and insufficient expansion at the...
Eligibility Criteria
Inclusion
- Scheduled to undergo unilateral or bilateral mastectomies for treatment of breast cancer with immediate tissue expander reconstruction
Exclusion
- Patients who have had previous immediate non-expander based breast reconstruction
- Patients who have had delayed secondary flap surgery (replacing expander with autogenous tissue)
- Patients who have pacemakers and/or defibrillators which are not compatible with CPX3
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01222390
Start Date
November 1 2010
End Date
April 1 2014
Last Update
April 6 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611