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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 22, 2013
Last verified: January 2013
History of Changes
  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(r) Biodesign(r) 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: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Establish the extent of nipple projection in all patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Geoffrey Gurtner, MD Stanford University
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01216319     History of Changes
Other Study ID Numbers: 09-009
Study First Received: October 5, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Biodesign
Nipple Reconstruction
Breast Cancer
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013