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Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

NCT00812097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 955

Last updated 2016-04-05

Study results available
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Summary

The Contour Profile Gel Study is designed to demonstrate safety and effectiveness 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.

Approximately 1000 patients at approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

Conditions

  • Breast Augmentation
  • Breast Reconstruction
  • Breast Revision

Interventions

DEVICE

Mentor Siltex® Contour Profile Gel Mammary Prosthesis

The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.

Sponsors & Collaborators

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • William P Adams Jr, M.D. · Dallas, TX

  • Dennis Hammond, M.D. · Grand Rapids, MI

  • John Canady, M.D. · Mentor Worldwide, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT00812097 on ClinicalTrials.gov