Discussion on Design of Clinical Trial Protocol of Laser Medical Devices.
10.3969/j.issn.1671-7104.2020.02.013
- Author:
Jianyuan WU
1
;
Zhimin HUANG
2
;
Junlong CAI
1
;
Bo CHEN
1
;
JIanying HUANG
1
Author Information
1. Clinical Trial Center of Zhongnan Hospital, Wuhan University, Wuhan, 430071.
2. Wuhan Pioon Technology Co., Ltd., Wuhan, 430000.
- Publication Type:Journal Article
- Keywords:
clinical trial;
laser;
medical devices;
protocol design
- MeSH:
Clinical Trial Protocols as Topic;
Equipment and Supplies;
Lasers;
Research Design
- From:
Chinese Journal of Medical Instrumentation
2020;44(2):158-162
- CountryChina
- Language:Chinese
-
Abstract:
Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.
