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

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. Identifier: NCT01216319
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : May 15, 2015
Last Update Posted : June 23, 2016
Information provided by (Responsible Party):
Cook Group Incorporated

October 5, 2010
October 7, 2010
April 30, 2015
May 15, 2015
June 23, 2016
September 2011
April 2014   (Final data collection date for primary outcome measure)
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) [ Time Frame: 12 months ]
Establish the extent of nipple projection in all patients [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01216319 on Archive Site
Rate of Patient Satisfaction [ Time Frame: 12 months ]
Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
Number of Adverse Events [ Time Frame: Up to 12 months ]
Not Provided
Not Provided
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Breast Reconstruction
  • Nipple Reconstruction
Device: Nipple reconstruction
Biodesign® Nipple Reconstruction Cylinder
Other Name: Biodesign
Experimental: Nipple Reconstruction Cylinder
Intervention: Device: Nipple reconstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Principal Investigator: Geoffrey Gurtner, MD Stanford University
Cook Group Incorporated
May 2016

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