Kidney StoneNCT07176026
Follow-Up of Ureteral Stones ≤4 mm
An observational study of Kidney Stone, run by Region Skane at 2 sites in Sweden.
Trial summary
The goal of this clinical trial is to evaluate the proportion of ureteral stones ≤4 mm that pass spontaneously within 4 and 8 weeks and assess if pain, blood test (S-creatinine), stone size, stone location and hydronephrosis can predict stone passage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- How many people
- 1,600 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Feb 2025to 1 Jan 2027
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients with acute renal colic where a CT within 24 hours shows a ureteral stone ≤ 4mm.
Who may be able to join
- all patients with acute renal colic where a CT within 24 hours shows an ureteral stone ≤ 4mm and there is no need for acute intervention.
Who cannot join
- Those who decline to participate, those who are put under guardianship or is less than 18 years old.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Department of Urology
Helsingborg
Department of Urology, KI Huddinge
Stockholm
About this study
Official title: Follow-Up of Ureteral Stones ≤4 mm: Evaluate the Proportion of Spontaneous Passage and Assess if Symptoms and Stone Characteristics Can Predict Stone Passage
The goal of this clinical trial is to evaluate the proportion of ureteral stones ≤4 mm that pass spontaneously within 4 and 8 weeks and assess if pain, blood test (S-creatinine), stone size, stone location and hydronephrosis can predict stone passage. The participants will be asked to fill in a questionare regarding symptoms, give a blood test and undergo a follow-up computed tomography.
Read the detailed description
All patients with a diagnosis of ureteral stone ≤4 mm at the Emergency Department in Helsingborg will be asked to participate. If they give consent data regarding age, gender, stone size, stone location, hydronephrosis, S-creatinine, treatments and results from the follow up CT is extraced from the medical records.
- Conditions
- Kidney Stone
- Medical subject headings
- Kidney Calculi
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 |
|---|---|---|
| Follow-up with S-creatine, questionnaire and CT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ureteral stones ≤ 4mm that pass spontaneously
Measured: From enrolement to passage of the stone or maximum 8 weeks.
Number of participants with residual pain
Residual pain is measured with VAS (visual analogue scale), values 0-10. VAS 0 = no pain and VAS 10 = worst possible pain.
Measured: From enrolement to passage of the stone or maximum 8 weeks.
Secondary outcomes (2)
QoL form including sick leave and return to full ADL
Questionnaire specifically designed for this study, including questions about pain (regarding pain: how often, how severe/ VAS, need for pain medication) and the ability/ inability to work as usual. VAS: visual analougus scale 0-10, 0 = no pain and 10 = worst possible pain.
Measured: From enrolement to passage of the stone or maximum 8 weeks.
Proportion of ureteral stone that have passed according to anatomical localisation, S-creatinine and presence of hydronephrosis.
Measured: From enrolement to passage of the stone or maximum 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Feb 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
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
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 8 Weeks
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176026
- Sponsor's protocol ID
- 2024-04897-01
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 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
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
- Follow-Up of Ureteral Stones ≤4 mm: Evaluate the Proportion of Spontaneous Passage and Assess if Symptoms and Stone Characteristics Can Predict Stone Passage
- ClinicalTrials.gov ID
- NCT07176026
- Acronym / sponsor ID
- 2024-04897-01
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Sep 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 clinical trial is to evaluate the proportion of ureteral stones ≤4 mm that pass spontaneously within 4 and 8 weeks and assess if pain, blood test (S-creatinine), stone size, stone location and hydronephrosis can predict stone passage. The participants will be asked to fill in a questionare regarding symptoms, give a blood test and undergo a follow-up computed tomography.
Detailed description
All patients with a diagnosis of ureteral stone ≤4 mm at the Emergency Department in Helsingborg will be asked to participate. If they give consent data regarding age, gender, stone size, stone location, hydronephrosis, S-creatinine, treatments and results from the follow up CT is extraced from the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up with S-creatine, questionnaire and CT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute renal colic where a CT within 24 hours shows a ureteral stone ≤ 4mm.
Key inclusion criteria (1 listed)
- all patients with acute renal colic where a CT within 24 hours shows an ureteral stone ≤ 4mm and there is no need for acute intervention.
Key exclusion criteria (1 listed)
- Those who decline to participate, those who are put under guardianship or is less than 18 years old.
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
Number of ureteral stones ≤ 4mm that pass spontaneously
Time frame: From enrolement to passage of the stone or maximum 8 weeks.
Number of participants with residual pain
Time frame: From enrolement to passage of the stone or maximum 8 weeks.
Residual pain is measured with VAS (visual analogue scale), values 0-10. VAS 0 = no pain and VAS 10 = worst possible pain.
2 secondary outcomes
QoL form including sick leave and return to full ADL
Time frame: From enrolement to passage of the stone or maximum 8 weeks.
Proportion of ureteral stone that have passed according to anatomical localisation, S-creatinine and presence of hydronephrosis.
Time frame: From enrolement to passage of the stone or maximum 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- 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.
Magnus Wagenius, PhD principal investigator
University of Lund
2 sites 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 2 sites 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: enrolling by invitation, 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of ureteral stones ≤ 4mm that pass spontaneously (time frame: From enrolement to passage of the stone or maximum 8 weeks.). The study lists 2 primary outcomes in all. 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.