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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Malignant Neoplasm of Breast

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

18 years and older

Sex

Female

Healthy volunteers

Not accepted

Sponsor

Novian Health Inc.

Last updated on ClinicalTrials.gov

February 19, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites