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A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Breast Reconstruction, Nipple Reconstruction

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Trial Information

A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the extent of nipple projection in all patients

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Geoffrey Gurtner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

09-009

NCT ID:

NCT01216319

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Reconstruction
  • Nipple Reconstruction
  • Biodesign
  • Nipple Reconstruction
  • Breast Cancer
  • Mastectomy
  • Breast Neoplasms

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317
Mercy Medical Center Baltimore, Maryland  21202
Park Meadows Cosmetic Surgery Lone Tree, Colorado  80124
Sanford Clinic Plastic and Reconstructive Surgery Sioux Falls, South Dakota  57105