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KMID : 1142220190140010043
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 1 p.43 ~ p.49
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A Study on Development of Guideline for Clinical Trial Standard Protocol of Endoscopic Marking System
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Kim You-Rim
Jeon Seong-Woo
Jang Won-Seuk
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Abstract
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Endoscopic marking system is a medical device used to mark the position of lesion found by endoscopy with clips and to detect it outside of the organ by such as laparoscope and remove lesion. The improvement of endoscopic technology and image could detect early lesions in the organ and wide use of minimal invasive surgery has led to the demand for development of new marking systems. Along with this trend, this research aims to suggest a guideline for Clinical Trial Standard Protocol of Endoscopic Marking System. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of new lesion marking systems by supporting a clinical trial plan.
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KEYWORD
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Endoscopy, Magnetic, Marking system, Clinical Trial, Guideline
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