DETECT Study: Duodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspectio
Recruiting
- Conditions
- Contamination<br />microorganisms<br />Disinfection<br />Reprocessing<br />complex flexible endoscopes<br />duodenoscopes<br />linear echoendoscopes<br />ERCP<br />EUS
- Registration Number
- NL-OMON29045
- Lead Sponsor
- Erasmus MC University Medical Center, Rotterdam, The Netherlands
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 870
Inclusion Criteria
A potential subject who meets the following criteria is eligible for participation in this study:
-ERCP duodenoscopes and linear echo-endoscopes that are:
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Flexible endoscope that is any other type than a duodenoscope or linear echo-endoscope.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess if usage of ATP tests in complex endoscopes, i.e. duodenoscopes and linear echo-endoscopes, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.
- Secondary Outcome Measures
Name Time Method 2) To assess the relation between the level of organic residue on DLE after manual cleaning, expressed as the amount of ATP in RLU, and the microbiological load on DLE after HLD, expressed as the number of colony forming units. <br /><br>3) To assess if the use of ATP tests after manual cleaning combined with re-cleaning protocols, facilitates a learning curve in the manual cleaning of duodenoscopes and linear echo-endoscopes, represented by a lower level of organic residue after manual cleaning.<br /><br>4) To assess which variables affect the costs of using ATP tests after manual cleaning of duodenoscopes and linear echo-endoscopes and the costs of microbial surveillance.