X射线计算机体层摄影设备临床评价

Clinical evaluation of X-ray CT equipment

X射线计算机体层摄影(CT)设备属大型医学影像设备,开展临床试验面临着诸多困难,急需审评机构明确CT设备临床评价的要求。CT设备临床评价可按照采集模式、重建方法和后处理功能划分为3个独立功能模块,采用不同的临床路径进行评价;成熟且风险已知的CT设备通常不需要进行临床试验;技术改进型CT设备的临床评价,支持性资料应与企业宣称的预期用途、技术风险及技术成熟程度相适应;如果非临床研究资料和样本临床图像可以证明产品的安全有效性,则不需要临床试验证据;进口产品可以利用上市后临床经验数据进行评价。明确CT设备临床评价要求,有助于指导该类产品生产企业准备适当的临床评价资料,减少不必要的临床试验,使其产品尽快获得上市应用,并使患者受益。

X-ray computed tomography(CT)equipment is a large imaging equipment,which faced many difficulties in implementing clinical trials.It is urgent for the evaluation organization to clarify the requirements of clinical evaluation of CT equipment.Clinical evaluation of CT equipment can be divided into three independent functional modules according to acquisition mode,reconstruction method and post-processing function,and different clinical pathways are adopted to implement evaluation.Mature CT equipment with known risks usually do not require clinical trials.For the clinical evaluation of CT equipment with technological improvement,the supporting data should be consistent with expected application,technical risk and technical maturity that were asserted by enterprise.Clinical trial evidence is not required if non-clinical research information and clinical images of samples can demonstrate the effectiveness of the safety of the products.Imported products can be evaluated by using the data of clinical experience of them after they went into marketing.Clarifying the requirements for clinical evaluation of CT equipment is helpful to guide the manufacturers of such products to prepare appropriate clinical evaluation data,to reduce unnecessary clinical trials,to make their products to obtain market application as soon as possible,and to benefit patients.