共聚焦显微成像系统P9000图像质量评价临床研究OACSTPCD

Objective To evaluate the effectiveness and safety of confocal microscopic imaging system P9000 in detecting human digestive tract tissues.Methods A total of 96 patients who underwent endoscopy in Dongfang Hospital of Beijing University of Chinese Medicine and Qilu Hospital of Shandong University from August 2021 to June 2022 were selected as study objects.A total of patients were included in the full analysis set(FAS)and 90 were included in the per protocol set(PPS).Through multicenter,randomized and self-controlled study,the consistency rate of image quality score and 95%CI of human digestive tract related tissues were detected by confocal microscopic imaging system P9000 and internationally recognized Cellvizio® system.At the same time,the operation time and adverse reactions of the two groups were also compared.Results In FAS and PPS,the consistency rate of image quality score and 95%CI of the two devices were 92.55%(87.25%-97.86%)and 92.22%(86.69%-97.76%),respectively,and the lower limit of 95%CI of the two analysis sets were greater than the target value of 84.6%.There was no significant difference in the operation time between the two groups(P>0.05).No adverse reactions caused by the equipment occurred in both groups.Conclusion The effectiveness and safety of the confocal microscopic imaging system P9000 can meet the design requirements,and it is worthy of clinical application.