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)

Stanford Investigator(s)

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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