CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Nipple reconstructiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01216319
NCT01216319N/ACompleted
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A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Cook Group Incorporated·interventional·Posted Oct 7, 2010·Updated Jun 23, 2016

In Brief

A clinical study evaluating Nipple reconstruction for Breast Cancer and 2 related conditions. Completed, enrolled 50 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Reconstruction, Nipple Reconstruction
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2010
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.7 years ago

Interventions

Nipple reconstructiondevice

Biodesign® Nipple Reconstruction Cylinder