DOBI Medical International has hired Beardsworth Consulting Group of Flemington, NJ, to manage the clinical trial of its ComfortScan optical imaging system.
Beardsworth will assist the Mahwah, NJ-based firm with patient recruitment, study management, site monitoring, and preparation of the FDA premarket approval (PMA) submission documents, according to DOBI.
The PMA clinical trial protocol requires the enrollment of approximately 1,200 patients between the ages of 18 and 50 to obtain at least 120 malignant scans for comparison with 120 benign cases, DOBI said. The trial will then determine the diagnostic results achieved by a combination of ComfortScan and mammography against the diagnostic results of mammography alone.
By AuntMinnie.com staff writers
November 3, 2005
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