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Following the Use of Gel Prosethetics in Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585884
Recruitment Status : Active, not recruiting
First Posted : January 3, 2008
Last Update Posted : February 8, 2013
Mentor Worldwide, LLC
Information provided by (Responsible Party):
University of California, Irvine

Brief Summary:
Following placement of silicone breast prosthetics for reconstruction

Condition or disease
Breast Cancer

Detailed Description:
Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Reconstruction or Revision
Study Start Date : January 2000
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women over 18 undergoing breast reconstruction

Inclusion Criteria:

  • Women undergoing breast surgery

Exclusion Criteria:

  • Collagen vascular disease, Scleroderma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585884

United States, California
The University of California Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Mentor Worldwide, LLC
Study Chair: Jeff Lewis Mentor Worldwide, LLC

Responsible Party: University of California, Irvine Identifier: NCT00585884     History of Changes
Other Study ID Numbers: 2000-1383
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by University of California, Irvine:
Reconstruction, Silicone prostheses