Status:
COMPLETED
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Lead Sponsor:
Cook Group Incorporated
Conditions:
Breast Cancer
Breast Reconstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Ni...
Eligibility Criteria
Inclusion
- Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.
- Patient presents with a desire to obtain nipple reconstruction
- Patient is at least 18 years of age
- And other inclusion criteria
Exclusion
- Patient is not medically fit enough for surgery under local anesthesia
- Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)
- Patient is pregnant, breastfeeding or planning further pregnancy during the study period
- Patient has physical allergies or cultural objections to the receipt of porcine products
- And other exclusion criteria
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01216319
Start Date
September 1 2011
End Date
April 1 2014
Last Update
June 23 2016
Active Locations (4)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Park Meadows Cosmetic Surgery
Lone Tree, Colorado, United States, 80124
3
Mercy Medical Center
Baltimore, Maryland, United States, 21202
4
Sanford Clinic Plastic and Reconstructive Surgery
Sioux Falls, South Dakota, United States, 57105