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

NCT ID: NCT01117701

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A - with SGW

Measurement of the forces needed to passage the ureteroscope in the ureter with a SGW in place.

Group Type EXPERIMENTAL

Ureteroscopy with and without safety guidewire

Intervention Type PROCEDURE

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.

B - without SGW

Measurement of the forces needed to passage the ureteroscope in the ureter without a SGW in place.

Group Type EXPERIMENTAL

Ureteroscopy with and without safety guidewire

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients planned for endoscopic kidney stone treatment

Exclusion Criteria

* Known pathology in the ureter
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helse-Bergen HF

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Helse Bergen HF, Haukeland University Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Øyvind Ulvik, MD

Role: PRINCIPAL_INVESTIGATOR

Helse Bergen HF, Haukeland University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helse Bergen HF, Haukeland University Hospital

Bergen, Bergen, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21835 (NSD) - 4

Identifier Type: OTHER

Identifier Source: secondary_id

102.09 (REK) - 4

Identifier Type: OTHER

Identifier Source: secondary_id

102.09 (REK) - 4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laser Lithotripsy for Ureteral Stones
NCT06465784 COMPLETED PHASE4