Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy

NCT ID: NCT03087812

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

Detailed Description

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:

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.

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).

Conditions

Kidney Stones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Office of the Endourological Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean de la Rosette, MD, PhD

Role: STUDY_CHAIR

Clinical Research Office of the Endourological Society

Locations

AMC University Hospital

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL201501

Identifier Type: -

Identifier Source: org_study_id