Following the Use of Gel Prosethetics in Breast Reconstruction

NCT ID: NCT00585884

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-02-01

Study Completion Date

2013-09-23

Brief Summary

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Following placement of silicone breast prosthetics for reconstruction

Detailed Description

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

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing breast surgery

Exclusion Criteria

* Collagen vascular disease, Scleroderma
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mentor Worldwide, LLC

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Gregory R. Evans

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff Lewis

Role: STUDY_CHAIR

Mentor Worldwide, LLC

Locations

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The University of California Irvine

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20001383

Identifier Type: -

Identifier Source: org_study_id

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