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Breast Reconstruction clinical trials

View clinical trials related to Breast Reconstruction.

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NCT ID: NCT00948948 Approved for marketing - Clinical trials for Breast Reconstruction

Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

Adjunct
Start date: n/a
Phase: N/A
Study type: Expanded Access

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.

NCT ID: NCT00811525 Approved for marketing - Clinical trials for Breast Reconstruction

Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant

CPG-CA
Start date: August 2004
Phase: N/A
Study type: Expanded Access

The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. With approval of MemoryShape™ Medium Height, Moderate Profile (CPG 321) Breast Implants on June 14, 2013, CPG CA Study subject enrollment has closed and the study has converted to a post approval study for this style.