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Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC) | Clinical Trials | Clareo Health

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

A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

NCT01216319•Cook Group Incorporated

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

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

Key Dates

Start Date

September 1, 2011

Primary Completion Date

April 1, 2014

Completion Date

April 1, 2014

Last Updated

June 23, 2016

Enrollment

ACTUAL participants

Conditions

Breast CancerBreast ReconstructionNipple Reconstruction

Interventions

Nipple reconstruction

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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: March 29, 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.

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

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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