Novian Health has begun a multicenter clinical trial on the use of its Novilase interstitial laser therapy (ILT) for the destruction of malignant breast tumors, the company said.
Novilase ILT is an image-guided, minimally invasive alternative for lumpectomy used to ablate small breast tumors. The new clinical trial is the first stage of a two-stage study as part of a U.S. Food and Drug Administration premarket approval (PMA) process, according to Novian Health.
Researchers will evaluate the rate of complete tumor ablation of breast cancers that are up to 2 cm, as well as the correlation of the pathology of postÂablation lumpectomy specimens with MRI, mammography, and ultrasound in detecting any residual tumor, the firm said. The first facility to participate in the trial is Rose Breast Center of Denver, CO.
