Following the Use of Gel Prosethetics in Breast Reconstruction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585884
First received: December 26, 2007
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

Following placement of silicone breast prosthetics for reconstruction


Condition
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Enrollment: 20
Study Start Date: January 2000
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women over 18 undergoing breast reconstruction

Criteria

Inclusion Criteria:

  • Women undergoing breast surgery

Exclusion Criteria:

  • Collagen vascular disease, Scleroderma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585884

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

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585884     History of Changes
Other Study ID Numbers: 2000-1383
Study First Received: December 26, 2007
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014