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Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Trial ID: NCT01216319
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.
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
- 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
- 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
- Patient has physical allergies or cultural objections to the receipt of porcine
- And other exclusion criteria
device: Nipple reconstruction
School of Medicine
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Stanford, CA 94305