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

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.

Completed

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Key information

Conditions

Ureteroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helse Bergen HF, Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients planned for endoscopic kidney stone treatment

Exclusion criteria

Known pathology in the ureter

Treatment and study plan

Ureteroscopy with and without safety guidewire

Procedure

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.

Primary outcomes

The force needed to passage the ureteroscope up and down in the ureter with and without SGW.

Time frame: 1 day

The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement.

Sponsors and collaborators

Lead sponsor

Helse-Bergen HF

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: May 5, 2010
Registry last updated: Mar 18, 2015

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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Completed