©2025 Stanford Medicine
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Not Recruiting
Trial ID: NCT01216319
Purpose
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® Nipple Reconstruction Cylinder.
Official Title
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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
Intervention(s):
device: Nipple reconstruction
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061