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Memory Gel og Shape kombineret kohorte (Glow)

2. november 2026 opdateret af: Mentor Worldwide, LLC

MemoryShape® og MemoryGel® brystimplantater efter godkendelse Ny tilmeldingsundersøgelse ("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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3603

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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 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.

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Enhed: 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.

Enhed: 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.
Eksperimentel: 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
Enhed: 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.

Enhed: 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.
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 MemoryGel® Breast Implants or MemoryShape® Breast Implants
Enhed: 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.

Enhed: 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.
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 MemoryGel® Breast Implants or MemoryShape® Breast Implants
Enhed: 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.

Enhed: 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.
Aktiv komparator: Other Aesthetic Surgery

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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
10 års Kaplan-Meier estimeret kumulativ incidensrate for forekomst af lokale komplikationer
Tidsramme: 10 år
10 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hyppigheder af forekomst af bindevævssygdom
Tidsramme: 10 år
10 år
Hyppigheder af forekomst af reumatologiske tegn og symptomer
Tidsramme: 10 år
10 år
Hyppigheder af forekomst af neurologiske tegn og symptomer
Tidsramme: 10 år
10 år
Hyppigheder af forekomst af kræft
Tidsramme: 10 år
10 år
Hyppigheder af forekomst af selvmord
Tidsramme: 10 år
10 år
Hyppigheder af amningskomplikationer
Tidsramme: 10 år
10 år
Hyppigheder af MR bekræftede brud
Tidsramme: 10 år
10 år
Effectiveness
Tidsramme: 10 years

Patient satisfaction rates
10 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
Tidsramme: Baseline, 10 years

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

Short Form 6a
Baseline, 10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mentor Worldwide, LLC

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. september 2016

Primær færdiggørelse (Anslået)

16. september 2031

Studieafslutning (Anslået)

16. september 2031

Datoer for studieregistrering

Først indsendt

23. september 2016

Først indsendt, der opfyldte QC-kriterier

27. september 2016

Først opslået (Anslået)

29. september 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-15-003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

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