An observational study in Kidney Stones, sponsored by Clinical Research Office of the Endourological Society. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Clinical Research Office of the Endourological Society · Observational
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 6 new ureteroscopes are used (3 from Olympus and 3 from Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Before the procedure is started the endoscope is tested for its microbiological load in two different ways:1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
After the procedure is finished, the endoscope is tested for its microbiological load in two different ways:
Transfer all samples to the lab as soon as possible but at least within four hours after collecting the samples.
As for the clinical efficacy during each procedure a detailed questionnaire about the use of each ureteroscope is filled out. This includes the ease of use making mention on quality of the image, torque, flexibility and durability.
Data will be collected through electronic case report forms (eCFRs), with use of an online Data Management system (DMS).
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's enrollment of 400 is above the median of 144 across 110 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Clinical Research Office of the Endourological Society is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population compromises those patients of over eighteen years old diagnosed to undergo a ureterorenoscopy (diagnostic or therapeutic) with a flexible ureterorenoscope.
Inclusion Criteria:
Microbiological load
To evaluate the pre-operative microbiological load of the tip and the working channel of the most common used flexible ureteroscopes, after high level disinfection
Time frame: 2 years
Durability
To evaluate the durability of the most common used flexible ureteroscopes in terms of number of procedures, total use time and total degrees of flexibility loss until the first repair is needed.
Time frame: 2 years
Factors affecting durability
To evaluate descriptive data on factors that may affect the durability of the flexible ureteroscopes. Factors measured are treatment time, treatment indication and anatomical location in the urinary tract, method of ureteroscope insertion number and type of accessory instrumentation through the working channel, difference in users, number of forcing the scope during the procedure and the number of disinfections.
Time frame: 2 years
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Clinical Research Office of the Endourological Society