DOBI Medical International Inc. this week reached agreement with the Food and Drug Administration (FDA) to conduct a multi-site clinical trial on its ComfortScan imaging system.
Results from DOBI's fifth and final pre-market approval (PMA) module to the FDA will be used to support ComfortScan's planned commercialization in the United States.
The ComfortScan system, an advanced development stage imaging device, is designed to provide a new means for the improved diagnosis of cancer though the detection of abnormal vascularization associated with tumors.
The study is expected to commence in the third quarter. Taking place at approximately a dozen research sites in the United States, DOBI says it will involve the enrollment of up to 600 patients previously referred to biopsy following a suspicious or indeterminate initial finding. At the end of the clinical study, an independent group of physicians, blinded to the results of the biopsied patients, will interpret the scans acquired by the ComfortScan system.
DOBI says the clinical study design was developed in collaboration with the FDA and a number of medical experts in the field of angiogenesis, breast cancer management, and clinical trial design/management.