NCT01187745

Brief Summary

Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate kidneys for suspected renal stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

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

September 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

August 23, 2010

Last Update Submit

June 27, 2011

Conditions

Kidney Stones

Keywords

renal calculi

Outcome Measures

Primary Outcomes (1)

  • The detection of kidney stones on ultrasound compared to CT.

    One year

Secondary Outcomes (1)

  • Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected.

    one year

Study Arms (1)

suspect kidney stones

Patients presenting with flank abdominal pain

Other: CT Scan followed by ultrasound

Interventions

CT Scan followed by ultrasoundOTHER

A limited U/S is performed after the CT scan which is ordered by the Emergency Department physician.

Also known as: CT- computerized tomography, U/S - ultrasound
suspect kidney stones

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with flank pain in the emergency department, suspected to have kidney stones.

You may qualify if:

  • Adult, able to consent, flank pain

You may not qualify if:

  • Pregnant, unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Civic and General Campuses

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ania Kielar, MD FRCPC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

CA(1)