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

March 17, 2015 updated by: Helse-Bergen HF

Does a Safety Guidewire Adjacent to the Ureteroscope 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Helse Bergen HF, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

  • Known pathology in the ureter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse-Bergen HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 102.09 (REK) - 4 (OTHER: The National Committees for Research Ethics in Norway)
  • 21835 (NSD) - 4 (OTHER: Norway: Norwegian Social Science Data Services)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ureteroscopy

Clinical Trials on Ureteroscopy with and without safety guidewire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe