Kidney StoneNCT06805149
Evaluation of Emergency Computed Tomography in Suspected Renal Colic. This is an Observational Retrospective Study Aimed to Evaluate Emergency Computed Tomography in Patients at the Emergency Department in Helsingborg, Sweden, With Suspected Acute Renal Colic.
An observational study of Kidney Stone, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this observational study is to learn more about diagnostics in patients with suspected acute renal colic at the emergency department. The main questions it aims to answer are: How many patients with symtoms of urolithiasis have a stone in the urinary tract at the emergency computed tomography (CT) Location… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Stone
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 9 May 2023to 1 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at the emergency department in Helsingborg
Who may be able to join
- Patient at the emergency department with suspected acute renal colic and an emergency CT within 24 hours 10 May 2023 to 9 May 2024.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Emergency Computed Tomography in Suspected Renal Colic
The goal of this observational study is to learn more about diagnostics in patients with suspected acute renal colic at the emergency department. The main questions it aims to answer are:
- How many patients with symtoms of urolithiasis have a stone in the urinary tract at the emergency computed tomography (CT)
- Location and size of the stones.
- Evaluate time to intervention and closure and if this has changed due to emergency CT.
Participants are patients with symtoms of suspected acute renal colic at the emergency department in Helsingborg with an emergency CT within 24 hours.
Read the detailed description
Since October 2022 The National Guidelines in Sweden recommend emergency CT for patients with suspected acute renal colic at the emergency department. In May 2023 the Department of Urology implemented this new regime with emergency CT for these patients in collaboration with the Department of Emergency and the Department of Radiology. This study aims to evaluate the first year (May 2023 to May 2024) with this new regime. Data regarding these patients where gathered regarding decriptive data, data regarding the stone, interventions and follow up. The investigators aim to compare the data with data from a soon to be published (Scandinavian Journal of Urology) article evaluating the situation regarding these patients during one year 2018-2019.
- Conditions
- Kidney Stone
- Keywords
- Neprolithiasis, Kidney diseases, Urologic disease, Urinary calculi, Kidney calculi, Renal colic, Pain, Computed tomography, Urogenital disease
- Medical subject headings
- Kidney Calculi, Kidney Diseases, Urologic Diseases, Urinary Calculi, Renal Colic, Pain, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emergency CT: kidney stone? | Patients at the emergency department in Helsingborg with suspected acute renal colic with an CT within 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients with a kidney stone on emergency CT
Number of patients with a kidney stone on emergency CT. Size and location of the stone as well as time to intervention and closure for those with a stone.
Measured: From enrollment until the date participants are considered stone free, up to 6 months regarding participants with stone. For participants without a stone, the time frame extends over the duration of their hospitalization, up to 30 days.
Secondary outcomes (1)
Numbers of visits to the emergency department
Has the number of visits to the emergency department due to acute renal colic changed before and after implementation of emergencty CT
Measured: Time from enrollment until the date the participants are considered stone free, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start9 May 2023
- Primary completion1 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Wagenius, Senior consultant, PhD, Principal investigator, Urology Department Helsingborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805149
- Sponsor's protocol ID
- 2024-01345-01
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share participants data outside the research group at the moment.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emergency Computed Tomography in Suspected Renal Colic
- ClinicalTrials.gov ID
- NCT06805149
- Acronym / sponsor ID
- 2024-01345-01
- Conditions
- Kidney Stone
- Keywords
- Neprolithiasis, Kidney diseases, Urologic disease, Urinary calculi, Kidney calculi, Renal colic, Pain, Computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Feb 2025 (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.
The goal of this observational study is to learn more about diagnostics in patients with suspected acute renal colic at the emergency department. The main questions it aims to answer are:
- How many patients with symtoms of urolithiasis have a stone in the urinary tract at the emergency computed tomography (CT)
- Location and size of the stones.
- Evaluate time to intervention and closure and if this has changed due to emergency CT.
Participants are patients with symtoms of suspected acute renal colic at the emergency department in Helsingborg with an emergency CT within 24 hours.
Detailed description
Since October 2022 The National Guidelines in Sweden recommend emergency CT for patients with suspected acute renal colic at the emergency department. In May 2023 the Department of Urology implemented this new regime with emergency CT for these patients in collaboration with the Department of Emergency and the Department of Radiology. This study aims to evaluate the first year (May 2023 to May 2024) with this new regime. Data regarding these patients where gathered regarding decriptive data, data regarding the stone, interventions and follow up. The investigators aim to compare the data with data from a soon to be published (Scandinavian Journal of Urology) article evaluating the situation regarding these patients during one year 2018-2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency CT: kidney stone? | – | –Patients at the emergency department in Helsingborg with suspected acute renal colic with an CT within 24 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at the emergency department in Helsingborg
Key inclusion criteria (1 listed)
- Patient at the emergency department with suspected acute renal colic and an emergency CT within 24 hours 10 May 2023 to 9 May 2024.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of patients with a kidney stone on emergency CT
Time frame: From enrollment until the date participants are considered stone free, up to 6 months regarding participants with stone. For participants without a stone, the time frame extends over the duration of their hospitalization, up to 30 days.
Number of patients with a kidney stone on emergency CT. Size and location of the stone as well as time to intervention and closure for those with a stone.
1 secondary outcome
Numbers of visits to the emergency department
Time frame: Time from enrollment until the date the participants are considered stone free, up to 6 months.
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 16 Sep 2025.
- Individual participant dataSharing planned: No. We have no plans to share participants data outside the research group at the moment.
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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, Senior consultant, PhD principal investigator
Urology Department Helsingborg
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 16 Sep 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?
Numbers of patients with a kidney stone on emergency CT (time frame: From enrollment until the date participants are considered stone free, up to 6 months regarding participants with stone. For participants without a stone, the time frame extends over the duration of their hospitalization, up to 30 days.). 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 16 Sep 2025.