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[Prueba de dispositivo que no está aprobado o aprobado por la FDA de EE. UU.] (STANCE)

24 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

250

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Niccole Diaz
  • Número de teléfono: 407-694-0553
  • Correo electrónico: Niccole.Diaz@bd.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 82521
        • Reclutamiento
        • Defyne MD
        • Investigador principal:
          • Oren Tessler
        • Contacto:
    • California
      • Beverly Hills, California, Estados Unidos, 90210
        • Reclutamiento
        • The Practice Plastic Surgery
        • Investigador principal:
          • Kelly Killeen, MD, FACS
        • Contacto:
      • Huntington Beach, California, Estados Unidos, 92647
        • Reclutamiento
        • California Aesthetic Center
        • Investigador principal:
          • Steve Vu
        • Contacto:
      • Newport Beach, California, Estados Unidos, 92660
        • Reclutamiento
        • Newport Plastic and Reconstructive Surgery Associates
        • Investigador principal:
          • Hisham Seify
        • Contacto:
      • Newport Beach, California, Estados Unidos, 92660
        • Reclutamiento
        • Donald S Mowlds, MD A Professional Corporation
        • Contacto:
        • Investigador principal:
          • Donald S Mowlds, MD
      • Pasadena, California, Estados Unidos, 91101
        • Reclutamiento
        • Stewart Wang MD Inc.
        • Contacto:
        • Investigador principal:
          • Stewart Wang
      • San Diego, California, Estados Unidos, 92121
        • Retirado
        • Tim Sayed MD
      • San Diego, California, Estados Unidos, 92107
        • Reclutamiento
        • Charlie Chen MD., Corp
        • Investigador principal:
          • Charlie Chen
        • Contacto:
    • Colorado
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Reclutamiento
        • Beauty by Buford
        • Investigador principal:
          • Gregory Buford
        • Contacto:
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33431
        • Retirado
        • Sanctuary Plastic Surgery
      • Miami, Florida, Estados Unidos, 33134
        • Reclutamiento
        • Careaga Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Daniel Careaga, MD
      • Orlando, Florida, Estados Unidos, 32819
        • Reclutamiento
        • Aesthetic Enhancements Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Armando Soto
      • Orlando, Florida, Estados Unidos, 32827
        • Reclutamiento
        • Scazorla Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Sarah Cazorla, MD
      • St. Petersburg, Florida, Estados Unidos, 33710
        • Reclutamiento
        • Billington Plastic Surgery
        • Investigador principal:
          • Alicia Billington, MD
        • Contacto:
      • Tampa, Florida, Estados Unidos, 33606
        • Reclutamiento
        • VIVIFY Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Dallas Buchanan, MD
    • Georgia
      • Alpharetta, Georgia, Estados Unidos, 30005
        • Reclutamiento
        • The Graivier Center
        • Contacto:
        • Investigador principal:
          • David Hill, MD
      • Atlanta, Georgia, Estados Unidos, 30328
        • Reclutamiento
        • Monarch Plastic Surgery and Skin Renewal Center
        • Contacto:
        • Investigador principal:
          • Carmen Kavali
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60642
        • Reclutamiento
        • Iteld Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Lawrence Iteld, MD
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46290
        • Reclutamiento
        • Meridian Plastic Surgery Center
        • Contacto:
        • Investigador principal:
          • Bruce W Van Natta
    • Louisiana
      • Mandeville, Louisiana, Estados Unidos, 70448
        • Reclutamiento
        • Northshore Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Jeffrey Claiborne
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • The Washington University
        • Investigador principal:
          • Justin Sacks
        • Contacto:
          • Jeremy Eisele
          • Número de teléfono: 314-362-4639
          • Correo electrónico: jeisele@wustl.edu
    • Nevada
      • Reno, Nevada, Estados Unidos, 89511
        • Reclutamiento
        • Reno Tahoe Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Tiffany McCormack, MD
    • New Jersey
      • West Long Branch, New Jersey, Estados Unidos, 07764
        • Reclutamiento
        • VIP Plastic Surgery
        • Investigador principal:
          • Rahul Vemula
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10021
        • Reclutamiento
        • Luxurgery
        • Contacto:
          • Christina Uong
          • Número de teléfono: 212-508-0000
          • Correo electrónico: cku@luxurgery.com
        • Investigador principal:
          • Sachin Shridharani, MD
      • New York, New York, Estados Unidos, 10036
        • Reclutamiento
        • Plastic Surgery Institute of New York
        • Contacto:
        • Investigador principal:
          • Matthew DelMauro, MD
        • Sub-Investigador:
          • Adam Schaffner, MD
    • North Carolina
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Reclutamiento
        • H/K/B Surgery
        • Investigador principal:
          • Bill Kortesis, MD, FACS
        • Contacto:
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74137
        • Retirado
        • Essential Medical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • Pittsburgh Center for Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Armando Davila, MD
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • The Plastic Surgery Center of Nashville With HKB
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Mary Gingrass, MD
        • Sub-Investigador:
          • Melinda Haws
    • Texas
      • Dallas, Texas, Estados Unidos, 75219
        • Reclutamiento
        • Farah Naz Khan
        • Contacto:
        • Investigador principal:
          • Farah Khan
      • El Paso, Texas, Estados Unidos, 79936
        • Reclutamiento
        • Southwest Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Frank Agullo
      • Houston, Texas, Estados Unidos, 77024
        • Reclutamiento
        • Aesthetic Center for Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Kristi Hustak
      • San Antonio, Texas, Estados Unidos, 78257
        • Reclutamiento
        • Hill Country Plastic Surgery
        • Contacto:
        • Investigador principal:
          • Amita Shah
        • Sub-Investigador:
          • Scott Farber
      • San Antonio, Texas, Estados Unidos, 78258
        • Terminado
        • Next Stage Clinical Research
    • Utah
      • Draper, Utah, Estados Unidos, 84020
        • Reclutamiento
        • The Plastics Clinic
        • Investigador principal:
          • Jerry Chidester
        • Contacto:
    • Washington
      • Seattle, Washington, Estados Unidos, 98005
        • Reclutamiento
        • Athenix Advanced Plastic Surgery & Aesthetic Center
        • Contacto:
        • Investigador principal:
          • Gavin Dry
      • Vancouver, Washington, Estados Unidos, 98660
        • Reclutamiento
        • Allen Gabriel MD
        • Investigador principal:
          • Allen Gabriel
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

22 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GalaFlex Light Scaffold

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

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

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

Surgery performed without the use of a scaffold

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Periodo de tiempo: 24-months after index surgery

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient quality of life and satisfaction (12-month)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Device or procedure related adverse events
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

C. R. Bard

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de diciembre de 2024

Finalización primaria (Estimado)

1 de febrero de 2029

Finalización del estudio (Estimado)

1 de febrero de 2029

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2023

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2023

Publicado por primera vez (Actual)

14 de julio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • DVL-BR-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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