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Does a Safety Guidewire Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Does a Safety Guidewire Adjacent to the Ureteroscope Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01117701
Enrollment
40
Registered
2010-05-05
Start date
2010-05-31
Completion date
2012-12-31
Last updated
2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteroscopy

Brief summary

The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

Detailed description

Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter. Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction. The forces needed to move the ureteroscope in the ureter have not been investigated properly. The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

Interventions

In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW.

Sponsors

Helse-Bergen HF
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients planned for endoscopic kidney stone treatment

Exclusion criteria

* Known pathology in the ureter

Design outcomes

Primary

MeasureTime frameDescription
The force needed to passage the ureteroscope up and down in the ureter with and without SGW.1 dayThe force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026