Evaluation of the Cook Biodesign Plastic Surgery Matrix (NRC)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Cook

ClinicalTrials.gov Identifier:

NCT01216319

First received: October 5, 2010

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2010

Last Updated Date

January 22, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Establish the extent of nipple projection in all patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01216319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Cook Biodesign Plastic Surgery Matrix

Official Title ^ICMJE

A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix

Brief 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(r) Biodesign(r) Nipple Reconstruction Cylinder.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer
Breast Reconstruction
Nipple Reconstruction

Intervention ^ICMJE

Device: Nipple reconstruction

Biodesign® Nipple Reconstruction Cylinder

Other Name: Biodesign

Study Arm (s)

Experimental: Nipple Reconstruction Cylinder

Intervention: Device: Nipple reconstruction

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01216319

Other Study ID Numbers ^ICMJE

09-009

Has Data Monitoring Committee

Not Provided

Responsible Party

Cook

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Geoffrey Gurtner, MD

Stanford University

Information Provided By

Cook

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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