Previous study: BR-002 CLINICAL TRIAL

BR-002: A Multicenter Clinical Trial: “Ablation and Resection” of Novilase® interstitial laser thermal therapy for the ablation of small malignant breast tumors (Full enrollment – ​​April 2015)

The purpose of the BR-002 clinical trial:

The primary objective of the BR-002 clinical trial was to evaluate the success rate of tumor ablation for breast cancers that were 20 mm (2 cm) or smaller in size. To achieve this, the trial compared the results obtained from post-ablation MRI, ultrasound, and mammography imaging with the post-excision histology results to establish correlations.

In total, 61 subjects with malignant breast tumors participated in the trial, with enrollment taking place at 12 sites across the USA and the UK. The results showed that 98% of malignant breast tumors with a size of 15 mm or smaller and 91% of tumors with 20 mm or smaller were successfully destroyed through a single Novilase laser procedure. Notably, there was a high correlation between MRI imaging and pathology in evaluating the effectiveness of the Novilase laser procedure.

To learn more about the clinical trial, visit: www.ClinicalTrials.gov (#NCT01478438). The data was published in the Annals of Surgical Oncology (Ann Surg Oncol https://doi.org/10.1245/s10434-018-6623-2)