Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Trial ID or NCT#

NCT01216319

Status

not recruiting iconNOT RECRUITING

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 Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Geoffrey Gurtner

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov