Skip to content

Following the Use of Gel Prosethetics in Breast Reconstruction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00585884
Enrollment
3
Registered
2008-01-03
Start date
2001-02-01
Completion date
2013-09-23
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Reconstruction, Silicone prostheses

Brief summary

Following placement of silicone breast prosthetics for reconstruction

Detailed description

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

Interventions

None listed

Sponsors

Mentor Worldwide, LLC
CollaboratorINDUSTRY
University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Women undergoing breast surgery

Exclusion criteria

* Collagen vascular disease, Scleroderma

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026