Following the Use of Gel Prosethetics in Breast Reconstruction
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Irvine
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
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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) |
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 May 22, 2013