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 29, 2014
Last verified: January 2014

October 5, 2010
January 29, 2014
September 2011
February 2014   (final data collection date for primary outcome measure)
Establish the extent of nipple projection in all patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01216319 on ClinicalTrials.gov Archive Site
Number of Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Cook Biodesign Plastic Surgery Matrix
A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
February 2014
February 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01216319
09-009
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Geoffrey Gurtner, MD Stanford University
Cook
January 2014

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