Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 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)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Breast, reconstruction, silicone processed this record on October 27, 2016