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

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ClinicalTrials.gov Identifier: NCT01117701
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
Helse-Bergen HF

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.

Condition or disease Intervention/treatment Phase
Ureteroscopy Procedure: Ureteroscopy with and without safety guidewire Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Does a Safety Guidewire Adjacent to the Ureteroscope Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?
Study Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: A - with SGW
Measurement of the forces needed to passage the ureteroscope in the ureter with a SGW in place.
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.
Experimental: B - without SGW
Measurement of the forces needed to passage the ureteroscope in the ureter without a SGW in place.
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

  • Known pathology in the ureter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117701


Locations
Norway
Helse Bergen HF, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Helse-Bergen HF
Investigators
Principal Investigator: Øyvind Ulvik, MD Helse Bergen HF, Haukeland University Hospital

Responsible Party: Øyvind Ulvik, MD, Helse Bergen HF, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01117701     History of Changes
Other Study ID Numbers: 102.09 (REK) - 4
21835 (NSD) - 4 ( Other Identifier: Norway: Norwegian Social Science Data Services )
102.09 (REK) - 4 ( Other Identifier: The National Committees for Research Ethics in Norway )
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: June 2011