En undersøgelse af sikkerheden og effektiviteten af mentoren MemoryGel Ultra High Profile brystimplantater i større størrelse hos forsøgspersoner, der gennemgår primær brystrekonstruktion eller revisionsrekonstruktion (Athena)
2. november 2026 opdateret af: Mentor Worldwide, LLC
En undersøgelse af sikkerheden og effektiviteten af mentoren Glat og struktureret større størrelse MemoryGel Ultra High Profile brystimplantater hos forsøgspersoner, der gennemgår primær brystrekonstruktion eller revisionsrekonstruktion
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Montgomery, Alabama, Forenede Stater, 36117
- Plastic Surgery Associates of Montgomery
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Arizona
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Phoenix, Arizona, Forenede Stater, 85028
- Mosharrafa Plastic Surgery
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
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Scottsdale, Arizona, Forenede Stater, 85260
- Andres Plastic Surgery
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California
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Bakersfield, California, Forenede Stater, 93301
- Adventist Health Bakersfield
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Burbank, California, Forenede Stater, 91505
- Susan E Downey MD, Inc
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Los Gatos, California, Forenede Stater, 95032
- Liu Plastic Surgery
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Buckhead Plastic Surgery, P.C
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Savannah, Georgia, Forenede Stater, 31405
- Georgia Institute of Plastic Surgery
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Indiana
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Mishawaka, Indiana, Forenede Stater, 46545
- The Centre, PC
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals & Clinics
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- The University of Kansas
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott Northwestern Hospital
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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New York
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New York, New York, Forenede Stater, 10029
- The Mount Sinai Medical Center
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Ohio
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Centerville, Ohio, Forenede Stater, 45458
- Plastic Surgery Institute of Dayton
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Cincinnati, Ohio, Forenede Stater, 45227
- The Plastic Surgery Group
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Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic
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Columbus, Ohio, Forenede Stater, 43212
- The Ohio State University Plastic Surgery
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Medical Center
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19087
- Paul Glat, MD, PC
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Alcoa, Tennessee, Forenede Stater, 37701
- The Center for Dermatology and Plastic Surgery at Springbrook
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Chattanooga, Tennessee, Forenede Stater, 37403
- The Plastic Surgery Group PC
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
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Houston, Texas, Forenede Stater, 77030
- The University of Texas MD Anderson Cancer Center
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Temple, Texas, Forenede Stater, 76508
- Baylor Scott & White Health
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- UVA Health System
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Subject is female and is at least 18 years old
- A candidate for:
- Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)
- Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
- Subject understands and signs the Informed Consent
- Subject agrees to return device to Mentor if device is explanted
- Subject agrees to comply with follow-up procedures, including returning for all follow-up visits
- Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width
Exclusion Criteria:
- Subject is pregnant at time of enrollment
- Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
- Currently has uncontrolled diabetes (at time of screening or enrollment)
- Has nursed a child within 3 months of study enrollment
- Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
- Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection
- Infection or abscess anywhere in the body
- Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
- Anatomic or physiologic abnormality that could lead to significant postoperative adverse events
- Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment
- Anticipated need for use of ADM/mesh at the time of implant or implant exchange
- Subject is HIV positive
- Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
- Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 Larger Size MemoryGel Ultra High Profile Breast implants |
The Mentor smooth larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
Andre navne:
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Eksperimentel: 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 Larger Size MemoryGel Ultra High Profile Breast implants |
The Mentor smooth larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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10 års Kaplan-Meier estimeret kumulativ incidensrate for forekomst af enhver genoperation
Tidsramme: 10 år
|
10 år
|
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10 års Kaplan-Meier estimeret kumulativ incidensrate for forekomst af Baker III, IV kapselkontraktur
Tidsramme: 10 år
|
10 år
|
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10 års Kaplan-Meier estimeret kumulativ incidensrate for forekomst af infektion
Tidsramme: 10 år
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10 år
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10 års Kaplan-Meier estimeret kumulativ incidensrate for forekomst af eksplantation med eller uden erstatning
Tidsramme: 10 år
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10 år
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Mentor Worldwide, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2016
Primær færdiggørelse (Anslået)
31. januar 2029
Studieafslutning (Anslået)
31. januar 2029
Datoer for studieregistrering
Først indsendt
21. marts 2016
Først indsendt, der opfyldte QC-kriterier
25. marts 2016
Først opslået (Anslået)
31. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MEN-15-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .