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

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