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形状記憶ジェルとシェイプの組み合わせコホート (Glow)

2026年11月2日 更新者：Mentor Worldwide, LLC

MemoryShape® および MemoryGel® 乳房インプラントの承認後の新規登録試験 (「グロー試験」)

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

3603

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
デバイス：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.

デバイス：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.
実験的：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
デバイス：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.

デバイス：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.
実験的：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
デバイス：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.

デバイス：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.
実験的：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
デバイス：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.

デバイス：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.
アクティブコンパレータ：Other Aesthetic Surgery

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

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
局所合併症発生の10年カプラン・マイヤー推定累積発生率
時間枠：10年
10年

二次結果の測定

結果測定
メジャーの説明
時間枠
結合組織病の発生率
時間枠：10年
10年
リウマチ徴候および症状の発生率
時間枠：10年
10年
神経学的徴候および症状の発生率
時間枠：10年
10年
がんの発生率
時間枠：10年
10年
自殺の発生率
時間枠：10年
10年
授乳合併症の発生率
時間枠：10年
10年
MRIで破裂が確認された割合
時間枠：10年
10年
Effectiveness
時間枠：10 years

Patient satisfaction rates
10 years

その他の成果指標

結果測定
メジャーの説明
時間枠
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
時間枠：Baseline, 10 years

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

Short Form 6a
Baseline, 10 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Mentor Worldwide, LLC

捜査官

  • スタディディレクター：Medical Director、Mentor Worldwide, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年9月1日

一次修了 (推定)

2031年9月16日

研究の完了 (推定)

2031年9月16日

試験登録日

最初に提出

2016年9月23日

QC基準を満たした最初の提出物

2016年9月27日

最初の投稿 (推定)

2016年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • MEN-15-003

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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