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

[미국 FDA의 승인 또는 허가를 받지 않은 기기의 시험] (STANCE)

2026년 9월 24일 업데이트: C. R. Bard

Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Capsular contracture is the number one complication leading to revision surgery after breast augmentation(2-4) which has been commonly cited as impacting 10 to 20% of all breast augmentation patients.(5-10) A prospective, randomized controlled study of patients presenting with Baker grade III or IV capsular contracture will be undertaken to investigate the ability of P4HB (specifically GalaFLEX LITE™ Scaffold) to reduce the recurrence of clinically significant CC and/or malposition requiring surgical correction. The primary endpoint is a composite of capsular contracture recurrence and/or breast implant malposition recommended for surgery OR breast infections requiring oral or IV antibiotic treatment within 90 days of surgery and/or peri-implant fluid collection needing a drainage procedure within 10-90 days of surgery.

연구 유형

중재적

등록 (추정된)

250

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 82521
        • 모병
        • Defyne MD
        • 수석 연구원:
          • Oren Tessler
        • 연락하다:
    • California
      • Beverly Hills, California, 미국, 90210
        • 모병
        • The Practice Plastic Surgery
        • 수석 연구원:
          • Kelly Killeen, MD, FACS
        • 연락하다:
      • Huntington Beach, California, 미국, 92647
        • 모병
        • California Aesthetic Center
        • 수석 연구원:
          • Steve Vu
        • 연락하다:
      • Newport Beach, California, 미국, 92660
        • 모병
        • Newport Plastic and Reconstructive Surgery Associates
        • 수석 연구원:
          • Hisham Seify
        • 연락하다:
      • Newport Beach, California, 미국, 92660
        • 모병
        • Donald S Mowlds, MD A Professional Corporation
        • 연락하다:
        • 수석 연구원:
          • Donald S Mowlds, MD
      • Pasadena, California, 미국, 91101
        • 모병
        • Stewart Wang MD Inc.
        • 연락하다:
        • 수석 연구원:
          • Stewart Wang
      • San Diego, California, 미국, 92121
        • 빼는
        • Tim Sayed MD
      • San Diego, California, 미국, 92107
        • 모병
        • Charlie Chen MD., Corp
        • 수석 연구원:
          • Charlie Chen
        • 연락하다:
    • Colorado
      • Lone Tree, Colorado, 미국, 80124
        • 모병
        • Beauty by Buford
        • 수석 연구원:
          • Gregory Buford
        • 연락하다:
    • Florida
      • Boca Raton, Florida, 미국, 33431
        • 빼는
        • Sanctuary Plastic Surgery
      • Miami, Florida, 미국, 33134
        • 모병
        • Careaga Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Daniel Careaga, MD
      • Orlando, Florida, 미국, 32819
        • 모병
        • Aesthetic Enhancements Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Armando Soto
      • Orlando, Florida, 미국, 32827
      • St. Petersburg, Florida, 미국, 33710
        • 모병
        • Billington Plastic Surgery
        • 수석 연구원:
          • Alicia Billington, MD
        • 연락하다:
      • Tampa, Florida, 미국, 33606
        • 모병
        • VIVIFY Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Dallas Buchanan, MD
    • Georgia
      • Alpharetta, Georgia, 미국, 30005
        • 모병
        • The Graivier Center
        • 연락하다:
        • 수석 연구원:
          • David Hill, MD
      • Atlanta, Georgia, 미국, 30328
        • 모병
        • Monarch Plastic Surgery and Skin Renewal Center
        • 연락하다:
        • 수석 연구원:
          • Carmen Kavali
    • Illinois
      • Chicago, Illinois, 미국, 60642
        • 모병
        • Iteld Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Lawrence Iteld, MD
    • Indiana
      • Indianapolis, Indiana, 미국, 46290
        • 모병
        • Meridian Plastic Surgery Center
        • 연락하다:
        • 수석 연구원:
          • Bruce W Van Natta
    • Louisiana
      • Mandeville, Louisiana, 미국, 70448
        • 모병
        • Northshore Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Jeffrey Claiborne
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • The Washington University
        • 수석 연구원:
          • Justin Sacks
        • 연락하다:
    • Nevada
      • Reno, Nevada, 미국, 89511
        • 모병
        • Reno Tahoe Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Tiffany McCormack, MD
    • New Jersey
      • West Long Branch, New Jersey, 미국, 07764
        • 모병
        • VIP Plastic Surgery
        • 수석 연구원:
          • Rahul Vemula
        • 연락하다:
    • New York
      • New York, New York, 미국, 10021
        • 모병
        • Luxurgery
        • 연락하다:
        • 수석 연구원:
          • Sachin Shridharani, MD
      • New York, New York, 미국, 10036
        • 모병
        • Plastic Surgery Institute of New York
        • 연락하다:
        • 수석 연구원:
          • Matthew DelMauro, MD
        • 부수사관:
          • Adam Schaffner, MD
    • North Carolina
      • Huntersville, North Carolina, 미국, 28078
        • 모병
        • H/K/B Surgery
        • 수석 연구원:
          • Bill Kortesis, MD, FACS
        • 연락하다:
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74137
        • 빼는
        • Essential Medical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • 모병
        • Pittsburgh Center for Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Armando Davila, MD
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • The Plastic Surgery Center of Nashville With HKB
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Mary Gingrass, MD
        • 부수사관:
          • Melinda Haws
    • Texas
      • Dallas, Texas, 미국, 75219
        • 모병
        • Farah Naz Khan
        • 연락하다:
        • 수석 연구원:
          • Farah Khan
      • El Paso, Texas, 미국, 79936
      • Houston, Texas, 미국, 77024
        • 모병
        • Aesthetic Center for Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Kristi Hustak
      • San Antonio, Texas, 미국, 78257
        • 모병
        • Hill Country Plastic Surgery
        • 연락하다:
        • 수석 연구원:
          • Amita Shah
        • 부수사관:
          • Scott Farber
      • San Antonio, Texas, 미국, 78258
        • 종료됨
        • Next Stage Clinical Research
    • Utah
      • Draper, Utah, 미국, 84020
        • 모병
        • The Plastics Clinic
        • 수석 연구원:
          • Jerry Chidester
        • 연락하다:
    • Washington
      • Seattle, Washington, 미국, 98005
        • 모병
        • Athenix Advanced Plastic Surgery & Aesthetic Center
        • 연락하다:
        • 수석 연구원:
          • Gavin Dry
      • Vancouver, Washington, 미국, 98660
        • 모병
        • Allen Gabriel MD
        • 수석 연구원:
          • Allen Gabriel
        • 연락하다:

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

22년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  1. Genetically female ≥22 and ≤70 years of age;
  2. Breast augmentation subject with capsular contracture (Baker grade III or IV);
  3. Desires a new silicone implant with no more than a ± 150cc volume change in implant size;
  4. Planned revision approach via inframammary fold (IMF) incision;
  5. Willing and able to comply with the study procedures including the 2-year follow-up visit;
  6. Can complete all required study visits as scheduled (i.e., physically attend);
  7. Has reviewed and completed an FDA required Breast Implant Patient Decision Checklist (e.g., implant-specific provided by the manufacturer);
  8. Has compatible smart technology that can be used for downloading/using the electronic patient diary; and,
  9. Provision of signed and dated informed consent form.

Exclusion Criteria:

  1. BMI <18 or >35
  2. Existing and/or replacement implant size > 800 cc
  3. Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
  4. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment
  5. Abnormal breast findings on imaging within 1-year prior to randomization that have not been determined to be benign
  6. Subject reported current, or prior history of, Systemic Symptoms Associated with Breast Implants (SSBI - formerly referred to as BII (Breast Implant Illness))
  7. Infection present in the study breast(s) (day of index procedure (surgery) exclusions)
  8. Current or recent breastfeeding (within 3-months of enrollment) or history of mastitis within the 6-months prior to enrollment
  9. Prior or current diagnosis of breast cancer
  10. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results
  11. Has undergone prior chest radiation treatment
  12. Has received chemotherapy within the last 12 months
  13. Current or recent (within 1-year of enrollment) alcohol/substance abuse
  14. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.)
  15. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
  16. Planned use of any other matrix (synthetic, biosynthetic, or biological) in the study breast(s) other than the GalaFLEX LITE™ Scaffold used to fully wrap the implant
  17. Planned (within the 2-year follow-up time period) use of medical (e.g. montelukast/Singulair; zafirlukast/Accolate), physical (e.g. massage), or device assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s)
  18. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease)
  19. Concurrent or planned use (within the 2-year follow-up time period) of autologous fat transfer in the study breast(s)
  20. Planned (within the 2-year follow-up time period) elective cosmetic surgery on the study breast(s) (e.g., staged mastopexy; revision for implant size change)
  21. Currently enrolled or has plans to enroll in another interventional clinical study that would interfere with this study
  22. Is pregnant or plans to become pregnant during the study period
  23. Known allergy to tetracycline hydrochloride and/or kanamycin sulfate
  24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes
  25. Subject will not remain under the care of the investigator for all breast related plastic surgery procedures while enrolled in the study
  26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted)
  27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
  28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study
  29. Subject has an implant that was never commercially available in the United States
  30. Has been implanted with any silicone implant other than breast implants
  31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications (e.g., anticoagulants or antiplatelet medications such as Xarelto, Aspirin, or Eliquis. NSAIDs such as Celebrex, Ibuprofen, Meloxicam are not exclusionary).
  32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons
  33. Subjects planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). Subjects with stable weight after previous surgery or current GLP-1 agonists use are not excluded.

Day of Index Procedure (Surgery) Exclusion Criteria

  1. Has an extra-capsular rupture (breast implant silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
  2. Suspicions of cancer from intraoperative capsule appearance such as capsule masses (based on surgical opinion/visual findings; does not require definitive pathology) inclusive of both BIA-ALCL and BIA-SCC; or,
  3. Presence of a systemic infection, infection at the surgical site, or infection anywhere in the body at the time of surgery.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GalaFlex Light Scaffold

Surgery performed with GalaFlex Lite Scaffold.
장치: GalaFLEX LITE™ Scaffold

Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
활성 비교기: Standard Surgery

Surgery performed using standard surgical procedures with no scaffold.
다른: Standard surgery

Surgery performed without the use of a scaffold

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
기간: 24-months after index surgery

Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition
24-months after index surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Patient quality of life and satisfaction (12-month)
기간: 12-months after index surgery

Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
12-months after index surgery
Patient quality of life and satisfaction
기간: 24-months after index surgery

Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
24-months after index surgery
Safety of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket, reduction of capsular contracture recurrence, and/or malposition
기간: 90 days

The occurrence of:

  • Breast fluid collection requiring a drainage procedure at any time, or after drain removal if one is used, within 90 days of surgery
  • Breast infection requiring oral (PO) or intravenous (IV) antibiotics related to the contracture revision surgery within 90 days of surgery
90 days

기타 결과 측정

결과 측정
측정값 설명
기간
Device or procedure related adverse events
기간: 24-months after index surgery

Select adverse events including: breast infection requiring PO or IV antibiotics related to the revision surgery; breast fluid collection requiring a drainage procedure; breast implant loss; any unscheduled/unanticipated breast reoperation; breast implant malposition recommended for surgery; skin necrosis; wound dehiscence; any seroma within 90 days of surgery; any hematoma within 90 days of surgery; capsular contracture Baker Grade >1; and red breast syndrome
24-months after index surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

C. R. Bard

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)

2024년 12월 12일

기본 완료 (추정된)

2029년 2월 1일

연구 완료 (추정된)

2029년 2월 1일

연구 등록 날짜

최초 제출

2023년 7월 6일

QC 기준을 충족하는 최초 제출

2023년 7월 6일

처음 게시됨 (실제)

2023년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • DVL-BR-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

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