Analysis of the key points of clinical application and clinical evaluation of capsule endoscope
10.3969/j.issn.1672-8270.2024.11.028
- VernacularTitle:胶囊内窥镜临床应用及临床评价关注要点分析
- Author:
Yidan ZHANG
1
;
Minqi LU
;
Niya LI
;
Weilu CHENG
;
Bin LIU
Author Information
1. 国家药品监督管理局医疗器械技术审评检查大湾区分中心 深圳 518045
- Keywords:
Medical device;
Capsule endoscope;
Clinical application;
Clinical evaluation;
Key points
- From:
China Medical Equipment
2024;21(11):151-156
- CountryChina
- Language:Chinese
-
Abstract:
By summarizing the clinical use of different capsule endoscopes in small intestine,colon,stomach and esophagus,the relevant evaluation indicators of the clinical application of capsule endoscopes for patients with different diseases were sorted out.Combined with the review process of capsule endoscopes that have been marketed at home and abroad,the key points of clinical evaluation of capsule endoscopes products in China that need to be marketed through clinical trials were considered.The clinical evaluation focuses included main evaluation index,secondary evaluation index and safety evaluation index,and the main evaluation index could consider the consistency rate of lesion diagnosis results and the excellent rate of image quality.The inclusion criteria for clinical trials of capsule endoscopy products were the population who intended to use the product,and the exclusion criteria need to consider the circumstances that were not applicable to such products and the circumstances that were not applicable to enrollment.
