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Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

NCT00948948 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2013-04-05

No results posted yet for this study

Summary

Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. This study is an "adjunct" study, which will encompass clinical reviews of reconstructive cases in all patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled mammary prostheses. This "adjunct" study will be accomplished under a limited clinical protocol in which specific parameters will be required but with controls somewhat less stringent than those normally required in Investigational Device Exemption (IDE) Trials.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

Silicone Gel-Filled Mammary Prostheses

Mentor Gel-Filled Mammary Prostheses are comprised of a shell made of medical grade silicone elastomer. Gel-filled implant devices manufactured by Mentor will be used in this study: * Gel-filled device which is available in smooth surface and textured surface (Siltex®) * Becker Expander/Mammary Prosthesis which is available in both the smooth and the textured (Siltex) version Both of these devices were originally indicated for both augmentation and reconstruction mammaplasty procedures, however for purposes of this study, indications are for reconstruction only.

Sponsors & Collaborators

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • Sue Schwefel · Mentor Worldwide, LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00948948 on ClinicalTrials.gov