Safety and Efficacy of Insight NM/CT Pro SPECT/CT via Clinical Trial
10.3969/j.issn.1005-5185.2024.11.014
- VernacularTitle:基于临床试验验证Insight NM/CT Pro SPECT/CT安全性与有效性
- Author:
Xu MA
1
,
2
;
Xuemei WANG
;
Guojian ZHANG
;
Jianbo LI
;
Lilei GAO
;
Fan LIU
Author Information
1. 内蒙古医科大学第一临床医学院,内蒙古 呼和浩特 010050
2. 乌兰察布市中心医院影像科,内蒙古 乌兰察布 012000
- Keywords:
Single photon emission computed tomography computed tomography;
Image quality;
Planar imaging;
Tomographic imaging
- From:
Chinese Journal of Medical Imaging
2024;32(11):1170-1175
- CountryChina
- Language:Chinese
-
Abstract:
Purpose To verify the safety and effectiveness of the Insight NM/CT Pro SPECT/CT Imaging System in clinical applications is verified through clinical validation of the acceptable rate of clinical image quality,commonly use features of the device,ease of use of the machine,satisfaction with the stability of the entire machine and safety evaluation.Materials and Methods A total of 79 subjects who voluntarily participated in the trial from July to October 2022 in the Affiliated Hospital of Inner Mongolia Medical University,were selected to undergo endocrine,circulatory,skeletal,respiratory and urological imaging for multiple systems using the Insight NM/CT Pro SPECT/CT,respectively.The quality of the images,the machine operation and safety were evaluated.Results The image quality of all 79 patients were evaluated.Of 36 cases,there were 35 cases of planar imaging were acceptable;Of 43 cases,there were 42 cases of tomographic imaging were acceptable,with an acceptability rate of 97.22%and 97.67%,respectively,and a lower limit of 95%CI of 85.47%and 87.71%,respectively,which were both higher than those of the target value(83.00%).When the operators performed imaging operations on 79 patients,the common functions of the equipment,the ease of use of the equipment and the stability of the whole machine were evaluated as a satisfaction rate of 100%,with no adverse events.Conclusion Insight NM/CT Pro SPECT/CT effectiveness fully meets the requirements of clinical applications,with clear images of tissue structure,full range of commonly used equipment features,stable system,and superior safety and reliability.
