NCT01117701

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 18, 2015

Status Verified

June 1, 2011

Enrollment Period

2.6 years

First QC Date

May 4, 2010

Last Update Submit

March 17, 2015

Conditions

Ureteroscopy

Outcome Measures

Primary Outcomes (1)

  • The force needed to passage the ureteroscope up and down in the ureter with and without SGW.

    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

Study Arms (2)

A - with SGW

EXPERIMENTAL

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

Procedure: Ureteroscopy with and without safety guidewire

B - without SGW

EXPERIMENTAL

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

Procedure: Ureteroscopy with and without safety guidewire

Interventions

Ureteroscopy with and without safety guidewirePROCEDURE

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.

A - with SGWB - without SGW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients planned for endoscopic kidney stone treatment

You may not qualify if:

  • Known pathology in the ureter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Bergen HF, Haukeland University Hospital

Bergen, Bergen, 5021, Norway

Location

MeSH Terms

Interventions

Ureteroscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Øyvind Ulvik, MD

    Helse Bergen HF, Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 18, 2015

Record last verified: 2011-06

Locations

NO(1)