Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061627) titled 'Evaluation of disinfection on gastrointestinal endoscopes using functional water, electrolyzed acid water and ozonated water' on May 20.
Study Type:
Observational
Primary Sponsor:
Institute - The Jikei University School of Medicine
Condition:
Condition - The flexible endoscopes for the gastrointestinal tract used for patients undergoing endoscopy.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to confirm that the effectiveness of the disinfection of the Clean Top KD-1 and the OED-1000S Plus ozone water-disinfector for flexible endoscopes for the digestive tract after clinical use is equivalent to that of the OER-6 water-disinfector.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - This applies to flexible gastrointestinal endoscopes used for the observation, diagnosis, imaging, and treatment of internal lumens, body cavities, the oral cavity, and the trachea in patients visiting the hospital for endoscopic examinations.
Key exclusion criteria - 1 Prion disease patients and flexible gastrointestinal endoscopes used on them.
2 Minor patients and flexible gastrointestinal endoscopes used on them.
3 Patients who refused to participate in the study and flexible gastrointestinal endoscopes used on them.
4 Cases where a water leak is detected during the pre-disinfection leak test of the endoscope.
5 Cases where the principal investigator or sub-investigator deems the implementation of the study inappropriate.
Target Size - 222
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 09 Month 25 Day
Date of IRB - 2024 Year 09 Month 25 Day
Anticipated trial start date - 2024 Year 11 Month 08 Day
Last follow-up date - 2025 Year 01 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063780
Disclaimer: Curated by HT Syndication.
