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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01216319
First received: October 5, 2010
Last updated: May 19, 2016
Last verified: May 2016

October 5, 2010
May 19, 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 ] [ Designated as safety issue: No ]
Establish the extent of nipple projection in all patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01216319 on ClinicalTrials.gov Archive Site
Rate of Patient Satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
Number of Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
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
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.
 
Completed
50
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01216319
09-009
Not Provided
Not Provided
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Geoffrey Gurtner, MD Stanford University
Cook
May 2016

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