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NCT Number: NCT03087812

Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy

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.

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Key information

About this study

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:

  • 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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
  • over 18 years
  • has signed informed consent
  • the patient is being treated with the designated flexible ureterorenoscope

Treatment and study plan

Primary outcomes

  1. Microbiological load

    Time frame: 2 years

    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

Secondary outcomes

  1. Durability

    Time frame: 2 years

    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.

  2. Factors affecting durability

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Clinical Research Office of the Endourological Society

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2017
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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