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

Completed · Not applicable

Conditions studied: Breast Cancer, Breast Reconstruction, Nipple Reconstruction

In brief

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.

Key facts

Study ID

NCT01216319

Run by

Cook Group Incorporated

People needed

50

Starts

2011-09-01

Expected to finish

2014-04-01

Last updated by the study team

2016-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Park Meadows Cosmetic Surgery — Lone Tree, Colorado, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Sanford Clinic Plastic and Reconstructive Surgery — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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