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COMPLETEDNANCT01216319

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

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® Ni...

Lead sponsor: Cook Group Incorporated•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cook Group Incorporated

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 23, 2016Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment50

Start dateSep 2011

Last updatedJun 23, 2016

Condition

Breast Cancer Breast Reconstruction Nipple Reconstruction

Locations shown

Stanford University School of Medicine

Stanford, California

Park Meadows Cosmetic Surgery

Lone Tree, Colorado

Mercy Medical Center

Baltimore, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2016Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions