Abstract: ObjectiveTo evaluate the efficacy and safety of Proviewer soft tissue access system used in intracranial operations and provide the scientific evidence for promotion and application. MethodsA prospective, randomized, controlled study was deployed. Proviewer is used in the treatment group and brain spatula in the control group to compare the clinical efficacy and the safety of operation between two groups. Results19 patients are fit into Full-Analysis Set(FAS) in our hospital(the First Affiliated Hospital With Nanjing Medical University) from June 2011 to Dec 2011, 10 patients are in treatment group and 9 in control group. 2 patients are removed because of age. There are 17 patients in Per-Protocol Set(PPS), 9 patients in the treatment group and 8 in the control group. There are 19 patients in Safety Set(SAS), 10 patients in the treatment group and 9 in the control group. The primary efficacy endpoint is clinical efficacy balanced score. There is statistical difference in FAS and PPS between two groups(P<0.05). The treatment group is superior to controlled group. And the same result is appeared in visual score and subjective description score(P<0.05) Adverse events are evaluated in safety. There is one patient(10.00%) in the treatment group and one patient(11.11%) in the controlled group. There is no statistic different in adverse events between two groups(P >0.05). All adverse events are not caused by the therapeutic device and disappear before leaving hospital. ConclusionCompared with the brain spatula, Proviewer soft tissue access system can provide better field of vision, convenient operation and decrease amount of bleeding in the operation. No adverse events appear related with the therapeutic device and it is worth popularization because of higher value of clinical application

Key words: Proviewer soft tissue access system, randomized controlled study, craniocerebral operation.