Renal ColicCLAD-VNCT06026072
Validation of the CLAD Score Ifor Renal Colic Pain
A study testing CLAD-V SCORE in people with Renal Colic, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- CLAD-V SCORE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2021to 30 Jul 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the emergency room for suspected renal colic
- Patient not objecting to participation
Who cannot join
- Patients unable to express their non-objection
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions.
This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.
Read the detailed description
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by a lithiasis creating a transient obstruction
Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis" (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of patients to the emergency room for renal colic
The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD score and the clinician's intuition is made available to practitioners in the emergency department.
All patients presenting to the emergency room for renal colic pain are eligible. The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. The doctor must then complete the questionnaire provided.
A reminder of the patient on D7 is carried out to collect information on the need for surgery after the emergency or not.
Each center ensures inclusions and reminders on D7 and will only transmit the database
- Conditions
- Renal Colic
- Being tested
- CLAD-V SCORE
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLAD-V SCOREOther
the CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no.
| Study group | Role | What they receive |
|---|---|---|
| CLAD-V | Other | All patient with renal colic will be eligible. The CLAD-V score will fills by the doctor and seven days after the patient will call back to know if he had a surgical intervention or no. Receives: Other: CLAD-V SCORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLAD-V performance
Validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start6 Jul 2021
- Primary completion6 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic BALEN, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026072
- Sponsor's protocol ID
- RC31/21/0124
- Other IDs
- 2021-A00807-34
- Acronym
- CLAD-V
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balen F, Cideron C, Noizet M, Bastouil M, Bucci R, Gil-Jardine C, Hebrard M, Moustafa F, Turki M, Oberlin M, Thiruganasambandamoorthy V. Predicting surgery within one week of emergency department presentation for renal colic using the CLAD-MB score: A prospective cohort study. Am J Emerg Med. 2026 Jan;99:381-385. doi: 10.1016/j.ajem.2025.10.052. Epub 2025 Oct 27.
PubMed 41175442
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain
- ClinicalTrials.gov ID
- NCT06026072
- Acronym / sponsor ID
- CLAD-V / RC31/21/0124
- Conditions
- Renal Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 6 Sep 2023 (actual)
- 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.
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions.
This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.
Detailed description
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by a lithiasis creating a transient obstruction
Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis" (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of patients to the emergency room for renal colic
The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD score and the clinician's intuition is made available to practitioners in the emergency department.
All patients presenting to the emergency room for renal colic pain are eligible. The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. The doctor must then complete the questionnaire provided.
A reminder of the patient on D7 is carried out to collect information on the need for surgery after the emergency or not.
Each center ensures inclusions and reminders on D7 and will only transmit the database
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
| Arm | Type | Receives |
|---|---|---|
| CLAD-V | Other | Other: CLAD-V SCOREAll patient with renal colic will be eligible. The CLAD-V score will fills by the doctor and seven days after the patient will call back to know if he had a surgical intervention or no. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients admitted to the emergency room for suspected renal colic
- Patient not objecting to participation
Key exclusion criteria (2 listed)
- Patients unable to express their non-objection
- Pregnant 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 |
|---|---|---|
| CLAD-V SCOREthe CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no. | Other | CLAD-V |
Primary outcome
CLAD-V performance
Time frame: 7 days
Validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain
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 6 Sep 2023.
- Derived from this study: PubMed 41175442Balen F, Cideron C, Noizet M, Bastouil M, Bucci R, Gil-Jardine C, Hebrard M, Moustafa F, Turki M, Oberlin M, Thiruganasambandamoorthy V. Predicting surgery within one week of emergency department presentation for renal colic using the CLAD-MB score: A prospective cohort study. Am J Emerg Med. 2026 Jan;99:381-385. doi: 10.1016/j.ajem.2025.10.052. Epub 2025 Oct 27.
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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.
Frederic BALEN principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLAD-V SCORE in people with Renal Colic, run by University Hospital, Toulouse 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 2 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 6 Sep 2023. 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?
CLAD-V performance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026072, which also lists 1 linked publication.
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 6 Sep 2023.