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Studies

Observational Recruiting

NCT06480955 on ClinicalTrials.gov

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

  • Sponsor: Cardiovascular and Interventional Radiological Society of Europe
  • Collaborators: Boston Scientific Corporation
  • Enrollment: 50 (Estimated)
  • Study start: 2025-04-01 (Actual)
  • Primary completion: 2027-04-01 (Estimated)
  • Study completion: 2028-04-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.

Conditions

  • Bone Metastases

Intervention / Treatment

  • Device: Cryoablation system

Primary Outcome Measures

  • Local progression-free survival rate (12 months)
    On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate

Countries

France, Spain, Switzerland

Locations and Investigators

  • Institute Bergonié, Bordeaux, France (Recruiting)
  • CHRU de Strasbourg, Strasbourg, France (Recruiting)
    • Roberto Luigi Cazzato, Dr (Principal Investigator)
  • Institut Gustave Roussy, Villejuif, France (Recruiting)
    • Frederic Deschamps, Dr (Principal Investigator)
  • Hospital Universitario y Politécnico La Fe, Valencia, Spain (Recruiting)
    • Fernando Gómez Muñoz, Dr (Principal Investigator)
  • CHUV-Lausanne University Hospital, Lausanne, Switzerland (Recruiting)
    • Georgia Tsoumakidou, Dr (Principal Investigator)

Study Officials

  • Roberto L Cazzato, Dr (Study Chair) — Strasbourg University Hospitals, Strasbourg, France