Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics
April 26, 2023 updated by: Gregory R. Evans, University of California, Irvine
Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
This trial will evaluate the outcome of placement of silicone breast prosthetics.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients will be evaluated for complications following placement of silicone breast prostheses.
Study Type
Observational
Enrollment (Actual)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Orange, California, United States, 92868
- The University of California, Irvine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
women undergoing breast reconstruction
Description
Inclusion Criteria:
- over 18 undergoing breast reconstruction
Exclusion Criteria:
- patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.
Study Closed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Silicone
patients undergoing placement of silicone breast prosthetics
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory Evans, The University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2002
Primary Completion (Actual)
December 19, 2013
Study Completion (Actual)
December 19, 2013
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2001-2192
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.