NCT01117688

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2015

Status Verified

June 1, 2011

Enrollment Period

2.6 years

First QC Date

May 4, 2010

Last Update Submit

March 31, 2015

Conditions

Urolithiasis

Keywords

Ureteroscopy

Outcome Measures

Primary Outcomes (1)

  • Stone free-rate

    3 months after treatment

Secondary Outcomes (3)

  • Hospital stay

    Up to 1 week after the operation

  • Complication rate

    Until 3 months after the procedure

  • Operating time

    Up to 1 day after the surgery

Study Arms (2)

B - without SGW

ACTIVE COMPARATOR

Ureteroscopy without SGW in place.

Procedure: Ureteroscopy with and without safety guidewire

A - with SGW

ACTIVE COMPARATOR

Ureteroscopy with SGW in place.

Procedure: Ureteroscopy with and without safety guidewire

Interventions

Ureteroscopy with and without safety guidewirePROCEDURE

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 SGWB - without SGW

Eligibility Criteria

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

You may qualify if:

  • Patients with urolithiasis planned for ureterorenoscopic treatment

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

Conditions

Urolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
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

April 1, 2015

Record last verified: 2011-06

Locations

NO(1)