Urinary NGAL and KIM-1 After ESWL

NCT ID: NCT07341269

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-10

Brief Summary

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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

Detailed Description

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Conditions

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Urinary Stone Renal Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing extracorporeal shock wave lithotripsy (SWL)

No Interventions

Intervention Type OTHER

No study-specific intervention; patients receive standard-of-care SWL.

No intervention

Intervention Type OTHER

No study-specific intervention; patients receive standard-of-care SWL.

Interventions

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No Interventions

No study-specific intervention; patients receive standard-of-care SWL.

Intervention Type OTHER

No intervention

No study-specific intervention; patients receive standard-of-care SWL.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years and older
* Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease

Exclusion Criteria

* 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
* Pregnancy
* Use of anticoagulant therapy
* History of cardiac arrhythmia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marmara University School of Medicine Urology Department

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR.UAD.0027

Identifier Type: -

Identifier Source: org_study_id

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