Performance characteristics and optimal cut-off value of triple adenylate nucleotides (A3) versus adenosine triphosphate (ATP) alone as a rapid test for predicting inadequate duodenoscope reprocessing

Not Applicable

Completed

• Conditions: This in not a study in human. It' s the study of duodenoscope cleanliness. No risk of health conditions

• Registration Number: TCTR20191210001
• Lead Sponsor: Kikkoman Biochemifa Company, Tokyo, Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-30
• Study Start: 2019-12-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All duodenoscopes (TJF-Q180V) that were used in ERCP procedure

Exclusion Criteria

none

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the performance characteristics of A3 test and ATP test before precleaning, after precleaning, after manual cleaning, after HLD step of duodenoscope reproce A3 test, Kikkoman biochemifa company & ATP test, 3M company

Secondary Outcome Measures

Name	Time	Method
AUROC of A3 test and ATP test for predicting bacterial contamination after duodenoscope reprocessing before precleaning, after precleaning, after manual cleaning, after HLD step of duodenoscope reproce SPSS program