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[Prova di un dispositivo non approvato o autorizzato dalla FDA degli Stati Uniti] (STANCE)

24 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 22 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comparatore attivo: Standard Surgery

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

Surgery performed without the use of a scaffold

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Lasso di tempo: 24-months after index surgery

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient quality of life and satisfaction (12-month)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Device or procedure related adverse events
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

C. R. Bard

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 dicembre 2024

Completamento primario (Stimato)

1 febbraio 2029

Completamento dello studio (Stimato)

1 febbraio 2029

Date di iscrizione allo studio

Primo inviato

6 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2023

Primo Inserito (Effettivo)

14 luglio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • DVL-BR-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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