UrolithiasisNCT00555308
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
A study testing emergency department targeted ultrasound imaging in people with Urolithiasis and Ultrasonography, run by Queen's University at 2 sites in Canada.
Trial summary
An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Urolithiasis, Ultrasonography, Hydronephrosis
- What is being tested?
- emergency department targeted ultrasound imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2007to Jun 2009
- Phase
- Interventional
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Emergency Department patients
- Males and Females
- Age 16-65
- Undergoing CT scan of the abdomen or formal ultrasound of the abdomen at Kingston General Hospital or Hotel Dieu Hospital in Kingston, Ontario.
Who cannot join
- Hemodynamic instability
- Fever
- Leukocytes or nitrites on dipstick urinalysis
- Pregnancy
- Renal failure
- Single functioning kidney or renal transplant
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hotel Dieu Hospital
Kingston, Ontario, K7L 2V7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
About this study
An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.
The objective of this study is to determine the accuracy of EDTU in patients suspected of renal colic. By demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate EDTU for hydronephrosis into standard emergency care in Canada.
- Conditions
- Urolithiasis, Ultrasonography, Hydronephrosis
- Being tested
- emergency department targeted ultrasound imaging
- Keywords
- urolithiasis, ultrasound, hydronephrosis
- Medical subject headings
- Urolithiasis, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency department targeted ultrasound imagingOther
Also called EDTU
bedside ultrasound performed by emergency physician to identify hydronephrosis
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | undergo EDTU Receives: Other: emergency department targeted ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of EDTU
Measured: 1 hour
Secondary outcomes (1)
same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Eric A Bruder, MD, Principal investigator, Queen's UniversityKieran M Moore, MD MMSc, Study director, Queen's UniversityLouise Rang, MD RDMS, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555308
- Sponsor's protocol ID
- EMED 094-07
- Other IDs
- PSI Grant Sept 2007
- Status last verified
- Jul 2009
- First submitted
- 7 Nov 2007
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
- ClinicalTrials.gov ID
- NCT00555308
- Acronym / sponsor ID
- EMED 094-07
- Conditions
- Urolithiasis, Ultrasonography, Hydronephrosis
- Keywords
- urolithiasis, ultrasound, hydronephrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Nov 2007 (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.
An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.
The objective of this study is to determine the accuracy of EDTU in patients suspected of renal colic. By demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate EDTU for hydronephrosis into standard emergency care in Canada.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Other: emergency department targeted ultrasound imagingundergo EDTU |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Emergency Department patients
- Males and Females
- Age 16-65
- Undergoing CT scan of the abdomen or formal ultrasound of the abdomen at Kingston General Hospital or Hotel Dieu Hospital in Kingston, Ontario.
Key exclusion criteria (6 listed)
- Hemodynamic instability
- Fever
- Leukocytes or nitrites on dipstick urinalysis
- Pregnancy
- Renal failure
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 |
|---|---|---|
| emergency department targeted ultrasound imagingAlso: EDTUbedside ultrasound performed by emergency physician to identify hydronephrosis | Other | one |
Primary outcome
Diagnostic accuracy of EDTU
Time frame: 1 hour
1 secondary outcome
same measures of diagnostic accuracy in the planned subgroup of patients being investigated for suspected renal colic
Time frame: 1 hour
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 22 Jul 2009.
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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.
Eric A Bruder, MD principal investigator
Queen's University
Kieran M Moore, MD MMSc study director
Queen's University
Louise Rang, MD RDMS study director
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emergency department targeted ultrasound imaging in people with Urolithiasis and Ultrasonography, run by Queen's University at 2 sites 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 4 inclusion and 6 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 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Diagnostic accuracy of EDTU (time frame: 1 hour). 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 22 Jul 2009.