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Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

This study is ongoing, but not recruiting participants.
Mentor Worldwide, LLC
Information provided by (Responsible Party):
Gregory R. Evans, University of California, Irvine Identifier:
First received: January 3, 2008
Last updated: November 11, 2012
Last verified: November 2012
This trial will evaluate the outcome of placement of silicone breast prosthetics.

Breast Cancer

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

Resource links provided by NLM:

Further study details as provided by Gregory R. Evans, University of California, Irvine:

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)
patients undergoing placement of silicone breast prosthetics

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women undergoing breast reconstruction

Inclusion Criteria:

  • over 18 undergoing breast reconstruction

Exclusion Criteria:

  • patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00594490

United States, California
The University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Mentor Worldwide, LLC
Principal Investigator: Gregory Evans The University of California, Irvine
  More Information

Responsible Party: Gregory R. Evans, Professor, University of California, Irvine Identifier: NCT00594490     History of Changes
Other Study ID Numbers: 2001-2192
Study First Received: January 3, 2008
Last Updated: November 11, 2012

Keywords provided by Gregory R. Evans, University of California, Irvine:
Breast, reconstruction, silicone processed this record on May 25, 2017