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Brief Title: Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery
Official Title: Evaluate the Effectiveness and Safety of the Raman IVD Analyzer for Intraoperative Glioma Diagnosis, Using Samples From Brain Resection Tissue (Prospective, Multicenter, Blind Evaluation, Single Group Target Value Method)
Study ID: NCT05901844
Brief Summary: Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.
Detailed Description: Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer. During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for paraffin pathological diagnosis. Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Tao Jiang, MD and PhD
Affiliation: Beijing Tiantan Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Qing Mao
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Dongming Yan
Affiliation: The First Affiliated Hospital of Zhengzhou University
Role: PRINCIPAL_INVESTIGATOR
Name: Shouwei Li
Affiliation: Capital Medical University
Role: PRINCIPAL_INVESTIGATOR