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[Proef van apparaat dat niet is goedgekeurd of goedgekeurd door de Amerikaanse FDA] (STANCE)

24 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

250

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

22 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GalaFlex Light Scaffold

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

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

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

Surgery performed without the use of a scaffold

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Tijdsspanne: 24-months after index surgery

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient quality of life and satisfaction (12-month)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Device or procedure related adverse events
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

C. R. Bard

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2024

Primaire voltooiing (Geschat)

1 februari 2029

Studie voltooiing (Geschat)

1 februari 2029

Studieregistratiedata

Eerst ingediend

6 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

6 juli 2023

Eerst geplaatst (Werkelijk)

14 juli 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • DVL-BR-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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