MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study (Glow Study)

Status: Active, not recruiting
Location: See all (78) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;

• Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;

• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

• Agrees to answer baseline questions;

• Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;

• Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and

• Has a valid e-mail address and access to the internet to complete online questionnaires.

• Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline implants) and is at least 22 years of age;

• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

• Agrees to answer baseline questions;

• Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and

• Has a valid e-mail address and access to the internet to complete online questionnaires.

• Received MemoryShape Breast Implants for breast augmenation after January 01, 2015 and was at least 22 years old (primary or revision) at the time of surgery OR underwent breast reconstruction (primary or revision) with MemoryShape Breast Implants after January 01, 2015. A women who has since had her MemoryShape Breast Implants explanted may still be enrolled in the study.

• Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;

• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

• Agrees to answer baseline questions;

• Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;

• Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and

• Has a valid e-mail address and access to the internet to complete online questionnaires.

Locations
United States
Alabama
Hedden Plastic Surgery Center
Birmingham
Plastic Surgery of Tuscaloosa
Tuscaloosa
Arkansas
Vanderpool Cosmetic Plastic Surgery
Fayetteville
Arizona
Advanced Plastic Surgery Institute
Gilbert
Advanced Surgical Associates
Mesa
Robles Plastic Surgery
Phoenix
Berardi Aesthetics and Plastic Surgery
Scottsdale
Guerra Plastic Surgery Center
Scottsdale
Mark Malek, MD Plastic Surgery
Scottsdale
California
Jaime Schwartz, MD
Beverly Hills
Susan E. Downey, MD Inc
Burbank
Mohebali Plastic Surgery
Corte Madera
Institute of Cosmetic and Reconstructive Surgery
Fountain Valley
Newport Beach Center for Plastic Surgery
Newport Beach
Newport Center for Special Surgery
Newport Beach
North Coast Plastic Surgery
Oceanside
Li Plastic Surgery
Ontario
Summit Plastic Surgery
Redding
Verve Plastic Surgery
Solana Beach
Kaweah Delta Health Care District
Visalia
Colorado
Park Meadows Cosmetic Surgery
Lone Tree
Florida
David Bogue MD, Plastic Surgery, PL
Boca Raton
The Plastic Surgery Institute of Miami
Coral Gables
University of Miami / Sylvester Comp Cancer Ctr
Coral Gables
South Florida Plastic Surgery
Fort Lauderdale
First Coast Plastic Surgery
Jacksonville
Christopher Craft Cosmetic Surgery
Miami
Imagos Plastic Surgery
Miami
Pierini Esthetic Surgery
Miami
Sean A. Simon, MD
Miami
Southeastern Plastic Surgery
Tallahassee
Dr. Joshua Halpern MD, PA
Tampa
Georgia
The Swan Center for Plastic Surgery
Alpharetta
Artisan Plastic Surgery
Atlanta
North Atlanta Plastic Surgery
Atlanta
Advanced Aesthetics
Fayetteville
Marietta Plastic Surgery
Marietta
Snodgrass and Robinson Plastic Surgery Specialists
Rome
The Georgia Institute for Plastic Surgery
Savannah
Iowa
Iowa Plastic Surgery
Davenport
Illinois
Barrington Plastic Surgery
Inverness
MAE Plastic Surgery
Northbrook
A New You Plastic Surgery & Laser Center
Oak Lawn
Michigan
AMAE Plastic & Reconstructive Surgery
Birmingham
Ellen A. Janetzke, MD
Bloomfield
Partners in Plastic Surgery
Grand Rapids
The Center for You
Traverse City
Danielle DeLuca-Pytell, MD, PC
Troy
Spa Renaissance & Renaissance Plastic Surgery
Troy
Minnesota
Gryskiewicz Twin Cities Cosmetic Surgery
Burnsville
Missouri
Parkcrest Plastic Surgery
Saint Louis
North Carolina
Piedmont Plastic Surgery & Dermatology - Blakeney
Charlotte
Providence Plastic Surgery & Skin Center
Charlotte
Piedmont Plastic Surgery & Dermatology - Cox Road
Gastonia
Piedmont Plastic Surgery & Dermatology Center - New Hope
Gastonia
Piedmont Plastic Surgery & Dermatology - Hickory
Hickory
Forsyth Plastic Surgery
Winston-salem
North Dakota
Advanced Surgical Arts Center
Bismarck
New Hampshire
Atlantic Plastic Surgery
Portsmouth
New Jersey
Summit Medical Group
Berkeley Heights
Nevada
Hankins and Sohn Plastic Surgery
Henderson
New York
Doctors Plastic Surgery
Long Island City
Ohio
The Columbus Institute for Plastic Surgery
Columbus
Carp Cosmetic Surgery
Uniontown
Oklahoma
Tim R. Love, M.D., P.C.
Oklahoma City
Pennsylvania
Paul Glat, MD, PC
Bala-cynwyd
South Carolina
Upstate Plastic Surgery
Greer
Tennessee
The Center for Dermatology and Plastic Surgery
Alcoa
Plastic Surgery Group
Chattanooga
Music City Plastic Surgery
Nashville
Texas
Ciaravino Plastic Surgery
Houston
Utah
Premier Plastic Surgery
Draper
Michael D. Marion Plastic Surgery
Lehi
Virginia
Plastic Surgery of Fredericksburg
Fredericksburg
Plastic Surgery Center of Hampton Roads
Newport News
The Hague Center for Cosmetic and Plastic Surgery
Norfolk
Richmond Plastic Surgeons
Richmond
Washington
Kai Morimoto MD PLLC
Spokane Valley
Time Frame
Start Date: September 1, 2016
Estimated Completion Date: June 30, 2032
Participants
Target number of participants: 3613
Treatments
Experimental: Primary Breast Augmentation
Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Experimental: Revision Breast Augmentation
Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants
Experimental: Primary Breast Reconstruction
Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Experimental: Revision Breast Reconstruction
Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Active Comparator: Other Aesthetic Surgery
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Sponsors
Leads: Mentor Worldwide, LLC

This content was sourced from clinicaltrials.gov

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