CartiHeal is pleased to announce the early completion of Subject enrollment for the Agili-C™ clinical study, following the Interim Analysis positive results.
In total 251 Subjects were enrolled, over a period of 2 years, in 26 sites in the US, Europe and Israel. Of these, 167 Subjects were enrolled into the Agili-C™ study arm and 84 Subjects were enrolled into the control arm; consistent with the 2:1 randomization ratio. According to the study design, the first Interim Analysis took place following enrollment of the first 250 Subjects.
Based on pre-specified criteria, early completion of enrollment was advised since the predictive probability of trial success with the current sample size is >0.95.