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

May 19, 2016 updated by: Cook Group Incorporated

A Single Arm Multicenter Study Evaluating 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® Nipple Reconstruction Cylinder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Park Meadows Cosmetic Surgery
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Clinic Plastic and Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • And other inclusion criteria

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
  • And other exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nipple Reconstruction Cylinder
Device: Nipple reconstruction
Biodesign® Nipple Reconstruction Cylinder
Other Names:
  • Biodesign

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Patient Satisfaction
Time Frame: 12 months
Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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