이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

메모리 젤 및 모양 결합 코호트 (Glow)

2026년 11월 2일 업데이트: Mentor Worldwide, LLC

MemoryShape® 및 MemoryGel® 유방 보형물 승인 후 신규 등록 연구("글로우 연구")

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

3603

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
장치: 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.

장치: 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.
실험적: 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
장치: 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.

장치: 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.
실험적: 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
장치: 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.

장치: 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.
실험적: 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
장치: 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.

장치: 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.
활성 비교기: Other Aesthetic Surgery

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

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
10년 Kaplan-Meier 추정 국소 합병증 발생 누적 발생률
기간: 10 년
10 년

2차 결과 측정

결과 측정
측정값 설명
기간
결합 조직 질환의 발생률
기간: 10 년
10 년
류마티스 징후 및 증상의 발생률
기간: 10 년
10 년
신경학적 징후 및 증상의 발생률
기간: 10 년
10 년
암 발생률
기간: 10 년
10 년
자살 발생률
기간: 10 년
10 년
수유 합병증 발생률
기간: 10 년
10 년
MRI 확인 파열 비율
기간: 10 년
10 년
Effectiveness
기간: 10 years

Patient satisfaction rates
10 years

기타 결과 측정

결과 측정
측정값 설명
기간
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
기간: Baseline, 10 years

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

Short Form 6a
Baseline, 10 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Mentor Worldwide, LLC

수사관

  • 연구 책임자: Medical Director, Mentor Worldwide, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 9월 1일

기본 완료 (추정된)

2031년 9월 16일

연구 완료 (추정된)

2031년 9월 16일

연구 등록 날짜

최초 제출

2016년 9월 23일

QC 기준을 충족하는 최초 제출

2016년 9월 27일

처음 게시됨 (추정된)

2016년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • MEN-15-003

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다