Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

This study is ongoing, but not recruiting participants.

First Received: January 3, 2008 Last Updated: July 14, 2008 History of Changes

Sponsor:	University of California, Irvine
Collaborator:	Mentor Corporation
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00594490

Purpose

This trial will evaluate the outcome of placement of silicone breast prosthetics.

Condition
Breast Cancer

Study Type:	Observational
Study Design:	Prospective
Official Title:	Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Silicone

Further study details as provided by University of California, Irvine:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	20
Study Start Date:	January 2001
Estimated Study Completion Date:	January 2025
Estimated Primary Completion Date:	January 2025 (Final data collection date for primary outcome measure)

Groups/Cohorts
Silicone patients undergoing placement of silicone breast prosthetics

Detailed Description:

Patients will be evaluated for complications following placement of silicone breast prostheses.

Eligibility

Study Population

women undergoing breast reconstruction

Criteria

Inclusion Criteria:

Exclusion Criteria:

patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594490

Locations

United States, California
The University of California, Irvine
Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

Mentor Corporation

Investigators

Principal Investigator:

Gregory Evans

The University of California, Irvine

More Information

No publications provided

Responsible Party:	Mentor Corporation ( Mentor Corporation )
Study ID Numbers:	2001-2192
Study First Received:	January 3, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00594490 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Irvine:

Breast, reconstruction, silicone

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010