Expired Study
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Orange, California 92868


Purpose:

Following placement of silicone breast prosthetics for reconstruction


Study summary:

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


Criteria:

Inclusion Criteria: - Women undergoing breast surgery Exclusion Criteria: - Collagen vascular disease, Scleroderma


Study is Available At:


Original ID:

2000-1383


NCT ID:

NCT00585884


Secondary ID:


Study Acronym:


Brief Title:

Following the Use of Gel Prosethetics in Breast Reconstruction


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeff Lewis
Study Chair
Mentor Worldwide, LLC

Study Dates

Start Date:January 2000
Completion Date:January 2025
Completion Type:Anticipated
Primary Completion Date:January 2025
Primary Completion Type:Anticipated
Verification Date:October 2018
Last Changed Date:October 9, 2018
First Received Date:December 26, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Mentor Worldwide, LLC

Samples and Retentions

Study Population: women over 18 undergoing breast reconstruction
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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