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Memory Gel und Shape Kombinierte Kohorte (Glow)

2. November 2026 aktualisiert von: Mentor Worldwide, LLC

MemoryShape®- und MemoryGel®-Brustimplantate nach Zulassung Neueinschreibungsstudie ("Glow-Studie")

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

3603

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35242
        • Hedden Plastic Surgery Center
      • Tuscaloosa, Alabama, Vereinigte Staaten, 35406
        • Plastic Surgery of Tuscaloosa
    • Arizona
      • Gilbert, Arizona, Vereinigte Staaten, 85295
        • Advanced Plastic Surgery Institute
      • Mesa, Arizona, Vereinigte Staaten, 85297
        • Advanced Surgical Associates
      • Phoenix, Arizona, Vereinigte Staaten, 85014
        • Robles Plastic Surgery
      • Scottsdale, Arizona, Vereinigte Staaten, 85260
        • Berardi Aesthetics and Plastic Surgery
      • Scottsdale, Arizona, Vereinigte Staaten, 85260
        • Guerra Plastic Surgery Center
      • Scottsdale, Arizona, Vereinigte Staaten, 85260
        • Mark Malek, MD Plastic Surgery
    • Arkansas
      • Fayetteville, Arkansas, Vereinigte Staaten, 72703
        • Vanderpool Cosmetic Plastic Surgery
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90210
        • Jaime Schwartz, MD
      • Burbank, California, Vereinigte Staaten, 91505
        • Susan E. Downey, MD Inc
      • Corte Madera, California, Vereinigte Staaten, 94925
        • Mohebali Plastic Surgery
      • Fountain Valley, California, Vereinigte Staaten, 92708
        • Institute of Cosmetic and Reconstructive Surgery
      • Newport Beach, California, Vereinigte Staaten, 92660
        • Newport Beach Center for Plastic Surgery
      • Newport Beach, California, Vereinigte Staaten, 92660
        • Newport Center for Special Surgery
      • Oceanside, California, Vereinigte Staaten, 92056
        • North Coast Plastic Surgery
      • Ontario, California, Vereinigte Staaten, 91764
        • Li Plastic Surgery
      • Redding, California, Vereinigte Staaten, 96001
        • Summit Plastic Surgery
      • Solana Beach, California, Vereinigte Staaten, 92075
        • Verve Plastic Surgery
      • Visalia, California, Vereinigte Staaten, 93291
        • Kaweah Delta Health Care District
    • Colorado
      • Lone Tree, Colorado, Vereinigte Staaten, 80124
        • Park Meadows Cosmetic Surgery
    • Florida
      • Boca Raton, Florida, Vereinigte Staaten, 33431
        • David Bogue MD, Plastic Surgery, PL
      • Coral Gables, Florida, Vereinigte Staaten, 33134
        • The Plastic Surgery Institute of Miami
      • Coral Gables, Florida, Vereinigte Staaten, 33146
        • University of Miami / Sylvester Comp Cancer Ctr
      • Fort Lauderdale, Florida, Vereinigte Staaten, 33308
        • South Florida Plastic Surgery
      • Jacksonville, Florida, Vereinigte Staaten, 32257
        • First Coast Plastic Surgery
      • Miami, Florida, Vereinigte Staaten, 33146
        • Sean A. Simon, MD
      • Miami, Florida, Vereinigte Staaten, 33166
        • Pierini Esthetic Surgery
      • Miami, Florida, Vereinigte Staaten, 33173
        • Imagos Plastic Surgery
      • Miami, Florida, Vereinigte Staaten, 33176
        • Christopher Craft Cosmetic Surgery
      • Tallahassee, Florida, Vereinigte Staaten, 32308
        • Southeastern Plastic Surgery
      • Tampa, Florida, Vereinigte Staaten, 33607
        • Dr. Joshua Halpern MD, PA
    • Georgia
      • Alpharetta, Georgia, Vereinigte Staaten, 30005
        • The Swan Center for Plastic Surgery
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • Artisan Plastic Surgery
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • North Atlanta Plastic Surgery
      • Fayetteville, Georgia, Vereinigte Staaten, 30214
        • Advanced Aesthetics
      • Marietta, Georgia, Vereinigte Staaten, 30060
        • Marietta Plastic Surgery
      • Rome, Georgia, Vereinigte Staaten, 30161
        • Snodgrass and Robinson Plastic Surgery Specialists
      • Savannah, Georgia, Vereinigte Staaten, 31405
        • The Georgia Institute for Plastic Surgery
    • Illinois
      • Inverness, Illinois, Vereinigte Staaten, 60067
        • Barrington Plastic Surgery
      • Northbrook, Illinois, Vereinigte Staaten, 60062
        • MAE Plastic Surgery
      • Oak Lawn, Illinois, Vereinigte Staaten, 60453
        • A New You Plastic Surgery & Laser Center
    • Iowa
      • Davenport, Iowa, Vereinigte Staaten, 52807
        • Iowa Plastic Surgery
    • Michigan
      • Birmingham, Michigan, Vereinigte Staaten, 48009
        • AMAE Plastic & Reconstructive Surgery
      • Bloomfield, Michigan, Vereinigte Staaten, 48304
        • Ellen A. Janetzke, MD
      • Grand Rapids, Michigan, Vereinigte Staaten, 49546
        • Partners in Plastic Surgery
      • Traverse City, Michigan, Vereinigte Staaten, 49684
        • The Center for You
      • Troy, Michigan, Vereinigte Staaten, 48083
        • Spa Renaissance & Renaissance Plastic Surgery
      • Troy, Michigan, Vereinigte Staaten, 48084
        • Danielle DeLuca-Pytell, MD, PC
    • Minnesota
      • Burnsville, Minnesota, Vereinigte Staaten, 55337
        • Gryskiewicz Twin Cities Cosmetic Surgery
    • Missouri
      • St Louis, Missouri, Vereinigte Staaten, 63141
        • Parkcrest Plastic Surgery
    • Nevada
      • Henderson, Nevada, Vereinigte Staaten, 89074
        • Hankins and Sohn Plastic Surgery
    • New Hampshire
      • Portsmouth, New Hampshire, Vereinigte Staaten, 03801
        • Atlantic Plastic Surgery
    • New Jersey
      • Berkeley Heights, New Jersey, Vereinigte Staaten, 07922
        • Summit Medical Group
    • New York
      • Long Island City, New York, Vereinigte Staaten, 11106
        • Doctors Plastic Surgery
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 28277
        • Piedmont Plastic Surgery & Dermatology - Blakeney
      • Charlotte, North Carolina, Vereinigte Staaten, 28277
        • Providence Plastic Surgery & Skin Center
      • Gastonia, North Carolina, Vereinigte Staaten, 28054
        • Piedmont Plastic Surgery & Dermatology - Cox Road
      • Gastonia, North Carolina, Vereinigte Staaten, 28054
        • Piedmont Plastic Surgery & Dermatology Center - New Hope
      • Hickory, North Carolina, Vereinigte Staaten, 28602
        • Piedmont Plastic Surgery & Dermatology - Hickory
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27103
        • Forsyth Plastic Surgery
    • North Dakota
      • Bismarck, North Dakota, Vereinigte Staaten, 58503
        • Advanced Surgical Arts Center
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43212
        • The Columbus Institute for Plastic Surgery
      • Uniontown, Ohio, Vereinigte Staaten, 44685
        • Carp Cosmetic Surgery
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
        • Tim R. Love, M.D., P.C.
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Vereinigte Staaten, 19087
        • Paul Glat, MD, PC
    • South Carolina
      • Greer, South Carolina, Vereinigte Staaten, 29650
        • Upstate Plastic Surgery
    • Tennessee
      • Alcoa, Tennessee, Vereinigte Staaten, 37701
        • The Center for Dermatology and Plastic Surgery
      • Chattanooga, Tennessee, Vereinigte Staaten, 37403
        • Plastic Surgery Group
      • Nashville, Tennessee, Vereinigte Staaten, 37215
        • Music City Plastic Surgery
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77098
        • Ciaravino Plastic Surgery
    • Utah
      • Draper, Utah, Vereinigte Staaten, 84020
        • Premier Plastic Surgery
      • Lehi, Utah, Vereinigte Staaten, 84043
        • Michael D. Marion Plastic Surgery
    • Virginia
      • Fredericksburg, Virginia, Vereinigte Staaten, 22401
        • Plastic Surgery of Fredericksburg
      • Newport News, Virginia, Vereinigte Staaten, 23606
        • Plastic Surgery Center of Hampton Roads
      • Norfolk, Virginia, Vereinigte Staaten, 23510
        • The Hague Center for Cosmetic and Plastic Surgery
      • Richmond, Virginia, Vereinigte Staaten, 23233
        • Richmond Plastic Surgeons
    • Washington
      • Spokane Valley, Washington, Vereinigte Staaten, 99216
        • Kai Morimoto MD PLLC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):

  1. 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;
  2. Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
  3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
  4. Agrees to answer baseline questions;
  5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
  6. 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
  7. 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):

  1. Has active infection anywhere in her body;
  2. 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;
  3. 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;
  4. Is currently pregnant or nursing;
  5. Is planning on undergoing or has undergone bariatric surgery; or
  6. 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):

  1. 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;
  2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
  3. Agrees to answer baseline questions;
  4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
  5. 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):

  1. Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
  2. Expects to undergo breast implant surgery during the study period;
  3. Has ever had silicone implants anywhere in her body;
  4. Has active infection anywhere in her body;
  5. Has a history of cancer of any kind, except non-melanoma skin cancer;
  6. 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;
  7. Is currently pregnant or nursing;
  8. Is planning on undergoing or has undergone bariatric surgery; or
  9. 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):

  1. 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.
  2. Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
  3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
  4. Agrees to answer baseline questions;
  5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
  6. 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
  7. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):

  1. Had an active infection anywhere in her body at the time of surgery;
  2. 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;
  3. 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;
  4. Was pregnant or nursing at the time of surgery;
  5. Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or
  6. 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
Gerät: 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.

Gerät: MemoryGel® Breast Implants

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.
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
Gerät: 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.

Gerät: MemoryGel® Breast Implants

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.
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
Gerät: 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.

Gerät: MemoryGel® Breast Implants

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.
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
Gerät: 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.

Gerät: MemoryGel® Breast Implants

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.
Aktiver Komparator: Other Aesthetic Surgery

Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Verfahren: Other Aesthetic Surgery

Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
10-Jahres-Kaplan-Meier-geschätzte kumulative Inzidenzrate des Auftretens lokaler Komplikationen
Zeitfenster: 10 Jahre
10 Jahre

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Häufigkeit des Auftretens von Bindegewebserkrankungen
Zeitfenster: 10 Jahre
10 Jahre
Häufigkeit des Auftretens rheumatologischer Anzeichen und Symptome
Zeitfenster: 10 Jahre
10 Jahre
Häufigkeit des Auftretens neurologischer Anzeichen und Symptome
Zeitfenster: 10 Jahre
10 Jahre
Häufigkeit des Auftretens von Krebs
Zeitfenster: 10 Jahre
10 Jahre
Suizidraten
Zeitfenster: 10 Jahre
10 Jahre
Raten von Laktationskomplikationen
Zeitfenster: 10 Jahre
10 Jahre
Raten der MRT bestätigten Ruptur
Zeitfenster: 10 Jahre
10 Jahre
Effectiveness
Zeitfenster: 10 years

Patient satisfaction rates
10 years

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
Zeitfenster: Baseline, 10 years

Short Form 4a
Baseline, 10 years
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities
Zeitfenster: Baseline, 10 years

Short Form 6a
Baseline, 10 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mentor Worldwide, LLC

Ermittler

  • Studienleiter: Medical Director, Mentor Worldwide, LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2016

Primärer Abschluss (Geschätzt)

16. September 2031

Studienabschluss (Geschätzt)

16. September 2031

Studienanmeldedaten

Zuerst eingereicht

23. September 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2016

Zuerst gepostet (Geschätzt)

29. September 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • MEN-15-003

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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