Ureteroscopy With and Without Safety Guidewire

NCT ID: NCT01117688

Last Updated: 2015-04-01

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

WITHDRAWN

Clinical Phase

NA

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 the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.

Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.

Detailed Description

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

The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.

However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.

The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

Conditions

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

Urolithiasis

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

B - without SGW

Ureteroscopy without SGW in place.

Group Type ACTIVE_COMPARATOR

Ureteroscopy with and without safety guidewire

Intervention Type PROCEDURE

In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.

A - with SGW

Ureteroscopy with SGW in place.

Group Type ACTIVE_COMPARATOR

Ureteroscopy with and without safety guidewire

Intervention Type PROCEDURE

In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed 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, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed 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 with urolithiasis planned for ureterorenoscopic treatment
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) - 3

Identifier Type: OTHER

Identifier Source: secondary_id

102.09 (REK) - 3

Identifier Type: OTHER

Identifier Source: secondary_id

102.09 (REK) - 3

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