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[Essai d'un appareil non approuvé ou autorisé par la FDA américaine] (STANCE)

24 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

250

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

22 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: GalaFlex Light Scaffold

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

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

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

Surgery performed without the use of a scaffold

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Délai: 24-months after index surgery

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient quality of life and satisfaction (12-month)
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Device or procedure related adverse events
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

C. R. Bard

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 décembre 2024

Achèvement primaire (Estimé)

1 février 2029

Achèvement de l'étude (Estimé)

1 février 2029

Dates d'inscription aux études

Première soumission

6 juillet 2023

Première soumission répondant aux critères de contrôle qualité

6 juillet 2023

Première publication (Réel)

14 juillet 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • DVL-BR-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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