Kidney StoneNCT06535711
Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
An observational study of Kidney Stone, run by Region Skane at 1 site in Sweden.
Trial summary
This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Acute CT and Deferred CT
- Type of treatment
- Surgery or procedure
- How many people
- 612 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2019to 3 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of urolithiasis at the Emergency Department during one year.
Who may be able to join
- Patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg
Who cannot join
- Patients with a locked medical record
Trial locations and contacts
1 site in 1 country.
About this study
This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department
Read the detailed description
All patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg was included during one year, 1 July 2019 to 30 June 2020. Data regarding size and location of stone, treatment, follow up was extracted from the medical records.
- Conditions
- Kidney Stone
- Being tested
- Acute CT, Deferred CT
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute CTRadiation
Acute CT (a CT within 24 h)
Deferred CTRadiation
Deferred CT (a CT within 3-4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Acute CT | Those with an acute CT (within 24 h). Receives: Radiation: Acute CT | |
| Deferred CT | Those without an acute CT, instead a CT within 3-4 weeks. Receives: Radiation: Deferred CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of interventions
Rate of ESWL (extracorporal shockwave lithotripsy), URS (ureteroscopy) and PCNL (percutanous nephrolithotripsy)
Measured: 1 year
Time to intervention
Time to intervention, measured in number of days
Measured: 1 year
Number of additional visits to the Emergency Department
Number of additional visits to the Emergency Department
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jul 2019
- Primary completion30 Jun 2020
- Study completion3 Apr 2025
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 Kidney StoneStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Wagenius, PhD, Principal investigator, University of Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535711
- Sponsor's protocol ID
- 2021-06913-01
- Status last verified
- Apr 2025
- First submitted
- 23 Jul 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Utter M, Altmark F, Popiolek M, Forsvall A, Lundstrom KJ, Thiel T, Wagenius M. Impact of emergency computed tomography on treatment and time to treatment for renal colic. Scand J Urol. 2025 Feb 5;60:29-35. doi: 10.2340/sju.v60.42593.
PubMed 39907293
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
- ClinicalTrials.gov ID
- NCT06535711
- Acronym / sponsor ID
- 2021-06913-01
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 2 Aug 2024 (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.
This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department
Detailed description
All patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg was included during one year, 1 July 2019 to 30 June 2020. Data regarding size and location of stone, treatment, follow up was extracted from the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute CT | – | Radiation: Acute CTThose with an acute CT (within 24 h). |
| Deferred CT | – | Radiation: Deferred CTThose without an acute CT, instead a CT within 3-4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of urolithiasis at the Emergency Department during one year.
Key inclusion criteria (1 listed)
- Patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg
Key exclusion criteria (1 listed)
- Patients with a locked medical record
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 |
|---|---|---|
| Acute CTAcute CT (a CT within 24 h) | Radiation | Acute CT |
| Deferred CTDeferred CT (a CT within 3-4 weeks) | Radiation | Deferred CT |
Primary outcome
Rate of interventions
Time frame: 1 year
Rate of ESWL (extracorporal shockwave lithotripsy), URS (ureteroscopy) and PCNL (percutanous nephrolithotripsy)
Time to intervention
Time frame: 1 year
Time to intervention, measured in number of days
Number of additional visits to the Emergency Department
Time frame: 1 year
Number of additional visits to the Emergency Department
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 Apr 2025.
- Derived from this study: PubMed 39907293Utter M, Altmark F, Popiolek M, Forsvall A, Lundstrom KJ, Thiel T, Wagenius M. Impact of emergency computed tomography on treatment and time to treatment for renal colic. Scand J Urol. 2025 Feb 5;60:29-35. doi: 10.2340/sju.v60.42593.
- Individual participant dataSharing planned: No
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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.
Magnus Wagenius, PhD principal investigator
University of Lund, Sweden
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 Stone, run by Region Skane at 1 site in Sweden.
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 6 Apr 2025. 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 Sweden. 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?
Rate of interventions (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT06535711, 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 Apr 2025.