We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216319
First Posted: October 7, 2010
Last Update Posted: June 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
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.

Condition Intervention
Breast Cancer Breast Reconstruction Nipple Reconstruction Device: Nipple reconstruction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Rate of Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.


Enrollment: 50
Study Start Date: September 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nipple Reconstruction Cylinder Device: Nipple reconstruction
Biodesign® Nipple Reconstruction Cylinder
Other Name: Biodesign

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216319


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Park Meadows Cosmetic Surgery
Lone Tree, Colorado, United States, 80124
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, South Dakota
Sanford Clinic Plastic and Reconstructive Surgery
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Geoffrey Gurtner, MD Stanford University
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01216319     History of Changes
Other Study ID Numbers: 09-009
First Submitted: October 5, 2010
First Posted: October 7, 2010
Results First Submitted: April 30, 2015
Results First Posted: May 15, 2015
Last Update Posted: June 23, 2016
Last Verified: May 2016

Keywords provided by Cook Group Incorporated:
Biodesign
Nipple Reconstruction
Breast Cancer
Mastectomy