Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
NRC
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
1 other identifier
interventional
50
1 country
4
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 Biodesign® Nipple Reconstruction Cylinder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Sep 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
May 15, 2015
CompletedJune 23, 2016
May 1, 2016
2.6 years
October 5, 2010
April 30, 2015
May 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
12 months
Secondary Outcomes (1)
Rate of Patient Satisfaction
12 months
Study Arms (1)
Nipple Reconstruction Cylinder
EXPERIMENTALInterventions
Biodesign® Nipple Reconstruction Cylinder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Stanford University School of Medicine
Stanford, California, 94305, United States
Park Meadows Cosmetic Surgery
Lone Tree, Colorado, 80124, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Sanford Clinic Plastic and Reconstructive Surgery
Sioux Falls, South Dakota, 57105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jason Hodde, Clinical Affairs Manager
- Organization
- Cook Biotech Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Gurtner, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 7, 2010
Study Start
September 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 23, 2016
Results First Posted
May 15, 2015
Record last verified: 2016-05