Urinary StoneNCT07341269
Urinary NGAL and KIM-1 After ESWL
An observational study of Urinary Stone and Renal Injury, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Stone, Renal Injury
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 10 Dec 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: The study population consists of adult patients aged 18 years and older with urinary system stone disease who are undergoing extracorporeal shock wave lithotripsy (SWL) as part of routine clinical care. Participants are prospectively observed to evaluate changes in urinary NGAL and KIM-1 levels as biomarkers of renal injury associated with SWL. Patients with active urinary tract infection, suspected struvite stones, urinary diversion, nephrostomy tube, bleeding disorders, pregnancy, anticoagulant use, or cardiac arrhythmia are excluded.
Who may be able to join
- Adults aged 18 years and older
- Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease
Who cannot join
- Positive nitrite on urinalysis prior to SWL
- Positive urine culture prior to SWL, defined as >10⁵ CFU/mL bacterial growth
- Suspected struvite stone, based on previous or partial stone analysis
- Presence of a nephrostomy tube
- Presence of urinary diversion
- History of bleeding disorders
Show all 9Show fewer
- Pregnancy
- Use of anticoagulant therapy
- History of cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Istanbul, 34854
About this study
Official title: Prospective Evaluation of the Effect of Different Intervals Between Extracorporeal Shock Wave Lithotripsy (ESWL) Sessions on Potential Renal Injury Using Urinary NGAL and KIM-1 Biomarkers
The goal of this prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease.
The main questions it aims to answer are:
Read more
Does the interval between consecutive ESWL sessions affect the degree of renal injury?
Are urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage?
What is the optimal time interval between ESWL sessions to minimize renal injury?
If there is a comparison group, researchers will compare patients undergoing ESWL with different inter-session time intervals to determine whether shorter or longer intervals are associated with higher levels of renal injury biomarkers.
Participants will:
Undergo ESWL treatment for urinary system stones
Be assigned to one of two groups based on the time interval between ESWL sessions
Provide urine samples before ESWL and after three ESWL sessions
Have urinary NGAL and KIM-1 levels measured to assess renal injury
- Conditions
- Urinary Stone, Renal Injury
- Being tested
- No Interventions, No intervention
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No study-specific intervention; patients receive standard-of-care SWL.
No interventionOther
No study-specific intervention; patients receive standard-of-care SWL.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing extracorporeal shock wave lithotripsy (SWL) | Not described Receives: Other: No Interventions; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary NGAL level
Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions
Measured: Within 2 weeks after completion of the third SWL session
Change in urinary KIM-1 levels
Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions
Measured: Within 2 weeks after completion of the third SWL session
Secondary outcomes (1)
Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals
Measured: Within 2 weeks after completion of the third SWL session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Aug 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341269
- Sponsor's protocol ID
- MAR.UAD.0027
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Effect of Different Intervals Between Extracorporeal Shock Wave Lithotripsy (ESWL) Sessions on Potential Renal Injury Using Urinary NGAL and KIM-1 Biomarkers
- ClinicalTrials.gov ID
- NCT07341269
- Acronym / sponsor ID
- MAR.UAD.0027
- Conditions
- Urinary Stone, Renal Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 14 Jan 2026 (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 prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease.
The main questions it aims to answer are:
Does the interval between consecutive ESWL sessions affect the degree of renal injury?
Are urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage?
What is the optimal time interval between ESWL sessions to minimize renal injury?
If there is a comparison group, researchers will compare patients undergoing ESWL with different inter-session time intervals to determine whether shorter or longer intervals are associated with higher levels of renal injury biomarkers.
Participants will:
Undergo ESWL treatment for urinary system stones
Be assigned to one of two groups based on the time interval between ESWL sessions
Provide urine samples before ESWL and after three ESWL sessions
Have urinary NGAL and KIM-1 levels measured to assess renal injury
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing extracorporeal shock wave lithotripsy (SWL) | – | Other: No Interventions, Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years and older with urinary system stone disease who are undergoing extracorporeal shock wave lithotripsy (SWL) as part of routine clinical care. Participants are prospectively observed to evaluate changes in urinary NGAL and KIM-1 levels as biomarkers of renal injury associated with SWL. Patients with active urinary tract infection, suspected struvite stones, urinary diversion, nephrostomy tube, bleeding disorders, pregnancy, anticoagulant use, or cardiac arrhythmia are excluded.
Key inclusion criteria (2 listed)
- Adults aged 18 years and older
- Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease
Key exclusion criteria (9 listed)
- Positive nitrite on urinalysis prior to SWL
- Positive urine culture prior to SWL, defined as >10⁵ CFU/mL bacterial growth
- Suspected struvite stone, based on previous or partial stone analysis
- Presence of a nephrostomy tube
- Presence of urinary diversion
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 |
|---|---|---|
| No InterventionsNo study-specific intervention; patients receive standard-of-care SWL. | Other | Patients undergoing extracorporeal shock wave lithotripsy (SWL) |
| No interventionNo study-specific intervention; patients receive standard-of-care SWL. | Other | Patients undergoing extracorporeal shock wave lithotripsy (SWL) |
Primary outcome
Change in urinary NGAL level
Time frame: Within 2 weeks after completion of the third SWL session
Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions
Change in urinary KIM-1 levels
Time frame: Within 2 weeks after completion of the third SWL session
Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions
1 secondary outcome
Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals
Time frame: Within 2 weeks after completion of the third SWL session
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 14 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urinary Stone and Renal Injury, run by Marmara University at 1 site in Turkey (Türkiye).
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 9 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 14 Jan 2026. 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 Turkey (Türkiye). 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?
Change in urinary NGAL level (time frame: Within 2 weeks after completion of the third SWL session). 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 14 Jan 2026.