Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.

Trial Details

NCT ID
NCT03463954
Phase
NA
Sponsor
Novian Health Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Novilase Laser ablation
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • La Jolla, California, United States|32.84727,-117.2742
  • Rancho Mirage, California, United States|33.73974,-116.41279
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Females, aged 18 years and older
  • Able to give written informed consent herself
  • Definitive pathologic diagnosis by needle core biopsy
  • Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest …

For full eligibility, visit ClinicalTrials.gov.

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