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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Helse-Bergen HF.
Recruitment status was  Active, not recruiting
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
  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
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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 September 14, 2014