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Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

Sponsor
University of California, Irvine (Other)
Overall Status
Completed
CT.gov ID
NCT00594490
Collaborator
Mentor Worldwide, LLC (Industry)
132
Enrollment
1
Location
138.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    132 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
    Actual Study Start Date :
    May 24, 2002
    Actual Primary Completion Date :
    Dec 19, 2013
    Actual Study Completion Date :
    Dec 19, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Silicone

    patients undergoing placement of silicone breast prosthetics

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • over 18 undergoing breast reconstruction
      Exclusion Criteria:
      • patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 The University of California, Irvine Orange California United States 92868

      Sponsors and Collaborators

      • University of California, Irvine
      • Mentor Worldwide, LLC

      Investigators

      • Principal Investigator: Gregory Evans, The University of California, Irvine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Gregory R. Evans, Professor, University of California, Irvine
      ClinicalTrials.gov Identifier:
      NCT00594490
      Other Study ID Numbers:
      • 2001-2192
      First Posted:
      Jan 15, 2008
      Last Update Posted:
      Apr 5, 2021
      Last Verified:
      Apr 1, 2021
      Keywords provided by Gregory R. Evans, Professor, University of California, Irvine
      Breast, reconstruction, silicone

      Study Results

      No Results Posted as of Apr 5, 2021