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Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Reconstruction or Revision


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Reconstruction or Revision


Patients undergoing breast reconstruction will be followed for outcomes after placement of
silicone prostheses


Inclusion Criteria:



- Women undergoing breast surgery

Exclusion Criteria:

- Collagen vascular disease, Scleroderma

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Jeff Lewis

Investigator Role:

Study Chair

Investigator Affiliation:

Mentor Worldwide, LLC

Authority:

United States: Food and Drug Administration

Study ID:

2000-1383

NCT ID:

NCT00585884

Start Date:

January 2000

Completion Date:

January 2025

Related Keywords:

  • Breast Cancer
  • Reconstruction, Silicone prostheses
  • Breast Neoplasms

Name

Location

The University of California IrvineOrange, California  92868