Acute Renal ColicIMAGENCONCT02878148
Conditional Imaging Prescription Strategy for Exploration of Acute Uncomplicated Renal Colic
A study testing Diagnostic imaging modalities for suspected renal colic in people with Acute Renal Colic and Nephrolithiasis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone. Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Colic, Nephrolithiasis
- What is being tested?
- Diagnostic imaging modalities for suspected renal colic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2016to 22 Feb 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Patient admitted to the Emergency department with suspected acute uncomplicated renal colic
Who cannot join
- Patient presenting with fever (>38°C)
- Patient with persisting pain despite administration of morphinic
- Patient presenting with anuria
- Patients with a single kidney and/or history of chronic renal failure
- Pregnant women or breastfeeding women
- Patient with a history of renal colic
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure
Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone.
Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone.
Read more
Patients will be followed up at 1 month to record the need for urologic intervention and its type.
The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT.
The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.
Read the detailed description
Plain abdominal Xray, Ultrasonography and unenhanced CT of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ED visit and within a 1 hour delay from each other.
Ultrasonography will be interpretated in combination to plain abdominal Xray, and independently from unenhanced CT, by two experienced radiologists blinded to the results of each other.
- Conditions
- Acute Renal Colic, Nephrolithiasis
- Being tested
- Diagnostic imaging modalities for suspected renal colic
- Keywords
- Nephrolithiasis, Ureteral stone, Acute renal colic, Ultrasonography, Computed tomography, Diagnosis
- Medical subject headings
- Renal Colic, Nephrolithiasis, Ureterolithiasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging modalities for suspected renal colicDevice
All patients with suspected acute uncomplicated renal colic included will undergo ultrasonography in addition to unenhanced CT of pelvis and abdomen and plain X-ray of the abdomen.
Imaging examination will be performed according to current guidelines.
Ultrasonography study and colour doppler will include the kidney, ureterovesical joint and ureters. Unenhanced CT will be performed using a dedicated low-dose protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected acute uncomplicated renal colic | Experimental | Diagnostic imaging Receives: Device: Diagnostic imaging modalities for suspected renal colic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)
Different conditional strategies will be evaluated a posteriori based on the targeted use or not of ultrasonography combined to plain X-ray and/or unenhanced CT, according to the patient's STONE score and BMI.
The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT (gold standard imaging modality)
Measured: Baseline
Secondary outcomes (3)
Radiation exposure dose according to the different imaging strategies tested
The reference strategy will be systematic unenhanced CT.
Measured: Baseline
Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management
Measured: Baseline
Diagnostic performances of the tested conditional strategies for alternative diagnosis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start17 Oct 2016
- Primary completion19 Jan 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal ColicStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire FAGET, MD, Principal investigator, Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878148
- Sponsor's protocol ID
- 9656
- Other IDs
- 2015-A01981-48
- Acronym
- IMAGENCO
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2016
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure
- ClinicalTrials.gov ID
- NCT02878148
- Acronym / sponsor ID
- IMAGENCO / 9656
- Conditions
- Acute Renal Colic, Nephrolithiasis
- Keywords
- Nephrolithiasis, Ureteral stone, Acute renal colic, Ultrasonography, Computed tomography, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 25 Aug 2016 (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.
Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone.
Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone.
Patients will be followed up at 1 month to record the need for urologic intervention and its type.
The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT.
The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.
Detailed description
Plain abdominal Xray, Ultrasonography and unenhanced CT of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ED visit and within a 1 hour delay from each other.
Ultrasonography will be interpretated in combination to plain abdominal Xray, and independently from unenhanced CT, by two experienced radiologists blinded to the results of each other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected acute uncomplicated renal colic | Experimental | Device: Diagnostic imaging modalities for suspected renal colicDiagnostic imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient
- Patient admitted to the Emergency department with suspected acute uncomplicated renal colic
Key exclusion criteria (7 listed)
- Patient presenting with fever (>38°C)
- Patient with persisting pain despite administration of morphinic
- Patient presenting with anuria
- Patients with a single kidney and/or history of chronic renal failure
- Pregnant women or breastfeeding women
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 |
|---|---|---|
| Diagnostic imaging modalities for suspected renal colicAll patients with suspected acute uncomplicated renal colic included will undergo ultrasonography in addition to unenhanced CT of pelvis and abdomen and plain X-ray of the abdomen. Imaging examination will be performed according to current guidelines. Ultrasonography study and colour doppler will include the kidney, ureterovesical joint and ureters. Unenhanced CT will be performed using a dedicated low-dose protocol. | Device | Patients with suspected acute uncomplicated renal colic |
Primary outcome
Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)
Time frame: Baseline
Different conditional strategies will be evaluated a posteriori based on the targeted use or not of ultrasonography combined to plain X-ray and/or unenhanced CT, according to the patient's STONE score and BMI. The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT (gold standard imaging modality)
3 secondary outcomes
Radiation exposure dose according to the different imaging strategies tested
Time frame: Baseline
Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management
Time frame: Baseline
Diagnostic performances of the tested conditional strategies for alternative diagnosis
Time frame: Baseline
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 25 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Claire FAGET, MD principal investigator
Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic imaging modalities for suspected renal colic in people with Acute Renal Colic and Nephrolithiasis, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 7 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 25 Oct 2019. 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 France. 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 performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality) (time frame: Baseline). 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 25 Oct 2019.