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

Ureteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117701
• Other study ID #: 102.09 (REK) - 4
• Secondary ID: 21835 (NSD) - 41
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: March 17, 2015
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Helse-Bergen HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

• Known pathology in the ureter

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ureteroscopy

Intervention

Procedure:
• Ureteroscopy with and without safety guidewire
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.

Locations

Country	Name	City	State
Norway	Helse Bergen HF, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The force needed to passage the ureteroscope up and down in the ureter with and without SGW.	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.	1 day	Yes