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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00812097
Other study ID # A105-0601-4
Secondary ID
Status Completed
Phase Phase 3
First received December 17, 2008
Last updated January 22, 2015
Start date February 2002
Est. completion date October 2014

Study information

Verified date January 2015
Source Mentor Worldwide, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Mentor Siltex® Contour Profile Gel Mammary Prosthesis
The CPG mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. The Siltex® shell is textured to provide a disruptive surface for collagen interface. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The thicker consistency provides a higher resistance to flow. The gel is made from the same materials as Mentor's standard silicone gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness. The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant. These marks help the physician orient the implant and ensure proper placement during implantation. CPG is available in sizes 120 cc-775 cc and 5 styles with various projection and height options.

Locations

Country Name City State
United States Mentor Worldwide, LLC Santa Barbara California

Sponsors (1)

Lead Sponsor Collaborator
Mentor Worldwide, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and a per patient basis. 10 years Yes
Primary Effectiveness will be determined by the changes in chest circumference and bra and cup size. 10 years No
Secondary Effectiveness will also be determined by changes in Quality of Life questionnaire results. 10 years No
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