Muistigeelin ja muodon yhdistetty kohortti (Glow)
MemoryShape®- ja MemoryGel®-rintaimplanttien hyväksymisen jälkeinen uusi rekisteröintitutkimus ("Glow Study")
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
The post-approval study will include a maximum of 3500 women undergoing breast augmentation or reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be included: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction. For the purpose of assessing rheumatological and neurological signs and symptoms, a control group with 300-480 women will be selected from the participating investigators' practices, who are undergoing an aesthetic surgery other than breast implant surgery. Breast implant patients and the concurrent control group patients will be followed for 10 years. Baseline and operative data will be collected at the beginning of the study, and follow-up data will be collected annually for 10 years through online questionnaires.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35242
- Hedden Plastic Surgery Center
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Tuscaloosa, Alabama, Yhdysvallat, 35406
- Plastic Surgery of Tuscaloosa
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Arizona
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Gilbert, Arizona, Yhdysvallat, 85295
- Advanced Plastic Surgery Institute
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Mesa, Arizona, Yhdysvallat, 85297
- Advanced Surgical Associates
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Phoenix, Arizona, Yhdysvallat, 85014
- Robles Plastic Surgery
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Scottsdale, Arizona, Yhdysvallat, 85260
- Berardi Aesthetics and Plastic Surgery
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Scottsdale, Arizona, Yhdysvallat, 85260
- Guerra Plastic Surgery Center
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Scottsdale, Arizona, Yhdysvallat, 85260
- Mark Malek, MD Plastic Surgery
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Arkansas
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Fayetteville, Arkansas, Yhdysvallat, 72703
- Vanderpool Cosmetic Plastic Surgery
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California
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Beverly Hills, California, Yhdysvallat, 90210
- Jaime Schwartz, MD
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Burbank, California, Yhdysvallat, 91505
- Susan E. Downey, MD Inc
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Corte Madera, California, Yhdysvallat, 94925
- Mohebali Plastic Surgery
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Fountain Valley, California, Yhdysvallat, 92708
- Institute of Cosmetic and Reconstructive Surgery
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Newport Beach, California, Yhdysvallat, 92660
- Newport Beach Center for Plastic Surgery
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Newport Beach, California, Yhdysvallat, 92660
- Newport Center for Special Surgery
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Oceanside, California, Yhdysvallat, 92056
- North Coast Plastic Surgery
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Ontario, California, Yhdysvallat, 91764
- Li Plastic Surgery
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Redding, California, Yhdysvallat, 96001
- Summit Plastic Surgery
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Solana Beach, California, Yhdysvallat, 92075
- Verve Plastic Surgery
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Visalia, California, Yhdysvallat, 93291
- Kaweah Delta Health Care District
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Colorado
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Lone Tree, Colorado, Yhdysvallat, 80124
- Park Meadows Cosmetic Surgery
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Florida
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Boca Raton, Florida, Yhdysvallat, 33431
- David Bogue MD, Plastic Surgery, PL
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Coral Gables, Florida, Yhdysvallat, 33134
- The Plastic Surgery Institute of Miami
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Coral Gables, Florida, Yhdysvallat, 33146
- University of Miami / Sylvester Comp Cancer Ctr
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Fort Lauderdale, Florida, Yhdysvallat, 33308
- South Florida Plastic Surgery
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Jacksonville, Florida, Yhdysvallat, 32257
- First Coast Plastic Surgery
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Miami, Florida, Yhdysvallat, 33146
- Sean A. Simon, MD
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Miami, Florida, Yhdysvallat, 33166
- Pierini Esthetic Surgery
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Miami, Florida, Yhdysvallat, 33173
- Imagos Plastic Surgery
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Miami, Florida, Yhdysvallat, 33176
- Christopher Craft Cosmetic Surgery
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Tallahassee, Florida, Yhdysvallat, 32308
- Southeastern Plastic Surgery
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Tampa, Florida, Yhdysvallat, 33607
- Dr. Joshua Halpern MD, PA
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Georgia
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Alpharetta, Georgia, Yhdysvallat, 30005
- The Swan Center for Plastic Surgery
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Atlanta, Georgia, Yhdysvallat, 30342
- Artisan Plastic Surgery
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Atlanta, Georgia, Yhdysvallat, 30342
- North Atlanta Plastic Surgery
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Fayetteville, Georgia, Yhdysvallat, 30214
- Advanced Aesthetics
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Marietta, Georgia, Yhdysvallat, 30060
- Marietta Plastic Surgery
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Rome, Georgia, Yhdysvallat, 30161
- Snodgrass and Robinson Plastic Surgery Specialists
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Savannah, Georgia, Yhdysvallat, 31405
- The Georgia Institute for Plastic Surgery
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Illinois
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Inverness, Illinois, Yhdysvallat, 60067
- Barrington Plastic Surgery
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Northbrook, Illinois, Yhdysvallat, 60062
- MAE Plastic Surgery
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Oak Lawn, Illinois, Yhdysvallat, 60453
- A New You Plastic Surgery & Laser Center
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Iowa
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Davenport, Iowa, Yhdysvallat, 52807
- Iowa Plastic Surgery
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Michigan
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Birmingham, Michigan, Yhdysvallat, 48009
- AMAE Plastic & Reconstructive Surgery
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Bloomfield, Michigan, Yhdysvallat, 48304
- Ellen A. Janetzke, MD
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Grand Rapids, Michigan, Yhdysvallat, 49546
- Partners in Plastic Surgery
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Traverse City, Michigan, Yhdysvallat, 49684
- The Center for You
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Troy, Michigan, Yhdysvallat, 48083
- Spa Renaissance & Renaissance Plastic Surgery
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Troy, Michigan, Yhdysvallat, 48084
- Danielle DeLuca-Pytell, MD, PC
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Minnesota
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Burnsville, Minnesota, Yhdysvallat, 55337
- Gryskiewicz Twin Cities Cosmetic Surgery
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Missouri
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St Louis, Missouri, Yhdysvallat, 63141
- Parkcrest Plastic Surgery
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Nevada
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Henderson, Nevada, Yhdysvallat, 89074
- Hankins and Sohn Plastic Surgery
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New Hampshire
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Portsmouth, New Hampshire, Yhdysvallat, 03801
- Atlantic Plastic Surgery
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New Jersey
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Berkeley Heights, New Jersey, Yhdysvallat, 07922
- Summit Medical Group
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New York
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Long Island City, New York, Yhdysvallat, 11106
- Doctors Plastic Surgery
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28277
- Piedmont Plastic Surgery & Dermatology - Blakeney
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Charlotte, North Carolina, Yhdysvallat, 28277
- Providence Plastic Surgery & Skin Center
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Gastonia, North Carolina, Yhdysvallat, 28054
- Piedmont Plastic Surgery & Dermatology - Cox Road
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Gastonia, North Carolina, Yhdysvallat, 28054
- Piedmont Plastic Surgery & Dermatology Center - New Hope
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Hickory, North Carolina, Yhdysvallat, 28602
- Piedmont Plastic Surgery & Dermatology - Hickory
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Winston-Salem, North Carolina, Yhdysvallat, 27103
- Forsyth Plastic Surgery
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North Dakota
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Bismarck, North Dakota, Yhdysvallat, 58503
- Advanced Surgical Arts Center
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Ohio
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Columbus, Ohio, Yhdysvallat, 43212
- The Columbus Institute for Plastic Surgery
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Uniontown, Ohio, Yhdysvallat, 44685
- Carp Cosmetic Surgery
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73120
- Tim R. Love, M.D., P.C.
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Yhdysvallat, 19087
- Paul Glat, MD, PC
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South Carolina
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Greer, South Carolina, Yhdysvallat, 29650
- Upstate Plastic Surgery
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Tennessee
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Alcoa, Tennessee, Yhdysvallat, 37701
- The Center for Dermatology and Plastic Surgery
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Chattanooga, Tennessee, Yhdysvallat, 37403
- Plastic Surgery Group
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Nashville, Tennessee, Yhdysvallat, 37215
- Music City Plastic Surgery
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Texas
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Houston, Texas, Yhdysvallat, 77098
- Ciaravino Plastic Surgery
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Utah
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Draper, Utah, Yhdysvallat, 84020
- Premier Plastic Surgery
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Lehi, Utah, Yhdysvallat, 84043
- Michael D. Marion Plastic Surgery
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Virginia
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Fredericksburg, Virginia, Yhdysvallat, 22401
- Plastic Surgery of Fredericksburg
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Newport News, Virginia, Yhdysvallat, 23606
- Plastic Surgery Center of Hampton Roads
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Norfolk, Virginia, Yhdysvallat, 23510
- The Hague Center for Cosmetic and Plastic Surgery
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Richmond, Virginia, Yhdysvallat, 23233
- Richmond Plastic Surgeons
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Washington
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Spokane Valley, Washington, Yhdysvallat, 99216
- Kai Morimoto MD PLLC
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
- 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.
Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
- Has active infection anywhere in her body;
- For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
- Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
- Is currently pregnant or nursing;
- Is planning on undergoing or has undergone bariatric surgery; or
- Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
- 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.
Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
- Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
- Expects to undergo breast implant surgery during the study period;
- Has ever had silicone implants anywhere in her body;
- Has active infection anywhere in her body;
- Has a history of cancer of any kind, except non-melanoma skin cancer;
- Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
- Is currently pregnant or nursing;
- Is planning on undergoing or has undergone bariatric surgery; or
- Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
- 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.
Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
- Had an active infection anywhere in her body at the time of surgery;
- For augmentation patients, had a history of cancer (prior to implantation) of any kind, except non-melanoma skin cancer; for reconstruction patients, had a history of cancer (prior to implantation) of any kind, except non melanoma skin cancer or adequately treated breast cancer;
- Had a confirmed diagnosis of connective tissue disease or neurological disease prior to implantation OR was being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
- Was pregnant or nursing at the time of surgery;
- Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or
- Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options. MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options. |
|
Kokeellinen: 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 |
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options. MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options. |
|
Kokeellinen: 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 |
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options. MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options. |
|
Kokeellinen: 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 |
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options. MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options. |
|
Active Comparator: Other Aesthetic Surgery
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise) |
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants) |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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10 vuoden Kaplan-Meier arvioi paikallisten komplikaatioiden kumulatiivisen ilmaantuvuuden
Aikaikkuna: 10 vuotta
|
10 vuotta
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Sidekudossairauksien esiintymistiheys
Aikaikkuna: 10 vuotta
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10 vuotta
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Reumatologisten merkkien ja oireiden esiintymistiheys
Aikaikkuna: 10 vuotta
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10 vuotta
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Neurologisten merkkien ja oireiden esiintymistiheys
Aikaikkuna: 10 vuotta
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10 vuotta
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Syövän esiintymistiheys
Aikaikkuna: 10 vuotta
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10 vuotta
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Itsemurhien esiintymistiheys
Aikaikkuna: 10 vuotta
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10 vuotta
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Imetyskomplikaatioiden määrä
Aikaikkuna: 10 vuotta
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10 vuotta
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MRI vahvisti repeämän
Aikaikkuna: 10 vuotta
|
10 vuotta
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Effectiveness
Aikaikkuna: 10 years
|
Patient satisfaction rates |
10 years
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
Aikaikkuna: Baseline, 10 years
|
Short Form 4a |
Baseline, 10 years
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PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities
Aikaikkuna: Baseline, 10 years
|
Short Form 6a |
Baseline, 10 years
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Mentor Worldwide, LLC
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvioitu)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- MEN-15-003
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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