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
N/A
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
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 Irvine | Orange, California 92868 |
