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[Prøvning af enhed, der ikke er godkendt eller godkendt af U.S. FDA] (STANCE)

24. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

22 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GalaFlex Light Scaffold

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

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

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

Surgery performed without the use of a scaffold

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Tidsramme: 24-months after index surgery

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient quality of life and satisfaction (12-month)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device or procedure related adverse events
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

C. R. Bard

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2024

Primær færdiggørelse (Anslået)

1. februar 2029

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

6. juli 2023

Først indsendt, der opfyldte QC-kriterier

6. juli 2023

Først opslået (Faktiske)

14. juli 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DVL-BR-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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