Kidney StonesNCT01187745
Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones
An observational study of Kidney Stones, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- CT Scan followed by ultrasound
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with flank pain in the emergency department, suspected to have kidney stones.
Who may be able to join
- Adult, able to consent, flank pain
Who cannot join
- Pregnant, unable to consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Ottawa Hospital Civic and General Campuses
Ottawa, Ontario, K1Y 4E9
About this study
Official title: Evaluation of Twinkling Artifact Compared to Computed Tomography for Evaluation of Kidney Stones
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.
Read the detailed description
All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included.
Pregnant patients will not be included.
- Conditions
- Kidney Stones
- Being tested
- CT Scan followed by ultrasound
- Keywords
- renal calculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Scan followed by ultrasoundOther
Also called CT- computerized tomography, U/S - ultrasound
A limited U/S is performed after the CT scan which is ordered by the Emergency Department physician.
| Study group | Role | What they receive |
|---|---|---|
| suspect kidney stones | Patients presenting with flank abdominal pain Receives: Other: CT Scan followed by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of kidney stones on ultrasound compared to CT.
Measured: One year
Secondary outcomes (1)
Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Ania Kielar, MD FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187745
- Sponsor's protocol ID
- 2009520-01H
- Status last verified
- Jun 2011
- First submitted
- 23 Aug 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Twinkling Artifact Compared to Computed Tomography for Evaluation of Kidney Stones
- ClinicalTrials.gov ID
- NCT01187745
- Acronym / sponsor ID
- 2009520-01H
- Conditions
- Kidney Stones
- Keywords
- renal calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included.
Pregnant patients will not be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspect kidney stones | – | Other: CT Scan followed by ultrasoundPatients presenting with flank abdominal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with flank pain in the emergency department, suspected to have kidney stones.
Key inclusion criteria (1 listed)
- Adult, able to consent, flank pain
Key exclusion criteria (1 listed)
- Pregnant, unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Scan followed by ultrasoundAlso: CT- computerized tomography, U/S - ultrasoundA limited U/S is performed after the CT scan which is ordered by the Emergency Department physician. | Other | suspect kidney stones |
Primary outcome
The detection of kidney stones on ultrasound compared to CT.
Time frame: One year
1 secondary outcome
Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ania Kielar, MD FRCPC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection of kidney stones on ultrasound compared to CT. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.