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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Helse-Bergen HF

ClinicalTrials.gov Identifier:

NCT01117701

First received: May 4, 2010

Last updated: June 24, 2011

Last verified: June 2011

History of Changes

Purpose

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	Intervention
Ureteroscopy	Procedure: Ureteroscopy with and without safety guidewire

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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?

Further study details as provided by Helse-Bergen HF:

Primary Outcome Measures:

The force needed to passage the ureteroscope up and down in the ureter with and without SGW. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	40
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

Known pathology in the ureter

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

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, 102.09 (REK) - 4
Study First Received:	May 4, 2010
Last Updated:	June 24, 2011
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services

ClinicalTrials.gov processed this record on May 19, 2013

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