RE:RE:Successfully treated?biggerr wrote: with those 12 patients the laser wasn't reaching the lower layers of cells, now that they've adjusted the frequency the things must have improved or they wouldn't be wasting their time getting new clinical sites
Maybe I'm wrong but I thought the errors were more in line with this.
Bladder Volume Calculation:
The clinical protocol did not clearly define the bladder volume calculation to be used by the pharmacy and the principal investigator to determine bladder size for administration of the Study Drug and Study Device, respectively. Average bladder volume voided over a 3 day period was used as opposed to a percentage of the maximum bladder volume voided.
Study Device Treatment Time:
The Study Device treatment time was based on detected bladder irradiance, which varied dramatically inside patient bladders due to shape, volume and bladder wall reflection. This led to undertreatment of certain patients with the Study Device by up to 87.9%. This has been modified to now determine Study Device treatment time based solely on the new bladder volume calculation, resulting in a more consistent Study Device treatment time across patients.
Summary:
The total of these Study II variances (Study Drug Volume, Study Device Volume and Study Device Treatment Time) have led to all 12 patients being undertreated by the Study Treatment from between 30.9% and 154.3