The primary endpoint will evaluate the mean ratio of the Actual Fraction of Cells Remaining (FCRa; as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as predicted by the Spectra Optia system FCR algorithm), in the Evaluable subject population. The trial started in November 2012 and the estimated completion date is May 2013.
More information: clinicaltrials.gov