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

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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Reconstruction Nipple Reconstruction Device: Nipple reconstruction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nipple Reconstruction Cylinder Device: Nipple reconstruction
Biodesign® Nipple Reconstruction Cylinder
Other Name: Biodesign




Primary Outcome Measures :
  1. Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Rate of Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Group Incorporated
Investigators
Principal Investigator: Geoffrey Gurtner, MD Stanford University

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01216319     History of Changes
Other Study ID Numbers: 09-009
First Posted: October 7, 2010    Key Record Dates
Results First Posted: May 15, 2015
Last Update Posted: June 23, 2016
Last Verified: May 2016

Keywords provided by Cook Group Incorporated:
Biodesign
Nipple Reconstruction
Breast Cancer
Mastectomy