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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014