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

ClinicalTrials.gov ID: NCT01216319

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01216319
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Cook Group Incorporated; Industry
Enrollment: 50 participants

Conditions and interventions

Conditions

Interventions

Nipple reconstruction Device

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2011 (Type not available)
Primary completion: Apr 2014 (Actual)
Completion: Apr 2014 (Actual)
Last update posted: Jun 23, 2016

2011 – 2014

United States locations

U.S. sites: 4
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
Stanford University School of Medicine	Stanford	California	94305	—
Park Meadows Cosmetic Surgery	Lone Tree	Colorado	80124	—
Mercy Medical Center	Baltimore	Maryland	21202	—
Sanford Clinic Plastic and Reconstructive Surgery	Sioux Falls	South Dakota	57105	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01216319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 23, 2016 · Synced Nov 15, 2026