En studie av sikkerheten og effektiviteten til mentoren MemoryGel Ultra High Profile brystimplantater i større størrelse hos personer som gjennomgår primær brystrekonstruksjon eller revisjonsrekonstruksjon (Athena)
2. november 2026 oppdatert av: Mentor Worldwide, LLC
En studie av sikkerheten og effektiviteten til mentoren glatte og strukturerte større MemoryGel Ultra High Profile brystimplantater hos personer som gjennomgår primær brystrekonstruksjon eller revisjonsrekonstruksjon
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
400
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Montgomery, Alabama, Forente stater, 36117
- Plastic Surgery Associates of Montgomery
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Arizona
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Phoenix, Arizona, Forente stater, 85028
- Mosharrafa Plastic Surgery
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Phoenix, Arizona, Forente stater, 85054
- Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
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Scottsdale, Arizona, Forente stater, 85260
- Andres Plastic Surgery
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California
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Bakersfield, California, Forente stater, 93301
- Adventist Health Bakersfield
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Burbank, California, Forente stater, 91505
- Susan E Downey MD, Inc
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Los Gatos, California, Forente stater, 95032
- Liu Plastic Surgery
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Stanford, California, Forente stater, 94305
- Stanford University School of Medicine
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- Buckhead Plastic Surgery, P.C
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Savannah, Georgia, Forente stater, 31405
- Georgia Institute of Plastic Surgery
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Indiana
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Mishawaka, Indiana, Forente stater, 46545
- The Centre, PC
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospitals & Clinics
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- The University of Kansas
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55407
- Abbott Northwestern Hospital
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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New York
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New York, New York, Forente stater, 10029
- The Mount Sinai Medical Center
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Ohio
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Centerville, Ohio, Forente stater, 45458
- Plastic Surgery Institute of Dayton
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Cincinnati, Ohio, Forente stater, 45227
- The Plastic Surgery Group
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Cleveland, Ohio, Forente stater, 44195
- The Cleveland Clinic
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Columbus, Ohio, Forente stater, 43212
- The Ohio State University Plastic Surgery
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Oregon
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Portland, Oregon, Forente stater, 97210
- Legacy Good Samaritan Medical Center
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forente stater, 19087
- Paul Glat, MD, PC
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Alcoa, Tennessee, Forente stater, 37701
- The Center for Dermatology and Plastic Surgery at Springbrook
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Chattanooga, Tennessee, Forente stater, 37403
- The Plastic Surgery Group PC
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, Forente stater, 77030
- Houston Methodist Hospital
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Houston, Texas, Forente stater, 77030
- The University of Texas MD Anderson Cancer Center
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Temple, Texas, Forente stater, 76508
- Baylor Scott & White Health
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- UVA Health System
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
10 års Kaplan-Meier estimert kumulativ insidensrate for forekomst av enhver reoperasjon
Tidsramme: 10 år
|
10 år
|
|
10 års Kaplan-Meier estimert kumulativ forekomstrate for forekomst av Baker III, IV kapselkontraktur
Tidsramme: 10 år
|
10 år
|
|
10 års Kaplan-Meier estimert kumulativ insidensrate for forekomst av infeksjon
Tidsramme: 10 år
|
10 år
|
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10 års Kaplan-Meier estimert kumulativ forekomstrate for forekomst av eksplantasjon med eller uten erstatning
Tidsramme: 10 år
|
10 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Mentor Worldwide, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2016
Primær fullføring (Antatt)
31. januar 2029
Studiet fullført (Antatt)
31. januar 2029
Datoer for studieregistrering
Først innsendt
21. mars 2016
Først innsendt som oppfylte QC-kriteriene
25. mars 2016
Først lagt ut (Antatt)
31. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MEN-15-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .