Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:59 AM
Study NCT ID:
NCT07341269
Status:
COMPLETED
Last Update Posted:
2026-01-14
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary NGAL and KIM-1 After ESWL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014545', 'term': 'Urinary Calculi'}], 'ancestors': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urinary NGAL and KIM-1'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-20', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urinary NGAL level', 'timeFrame': 'Within 2 weeks after completion of the third SWL session', 'description': 'Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions'}, {'measure': 'Change in urinary KIM-1 levels', 'timeFrame': 'Within 2 weeks after completion of the third SWL session', 'description': 'Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions'}], 'secondaryOutcomes': [{'measure': 'Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals', 'timeFrame': 'Within 2 weeks after completion of the third SWL session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Stone', 'Renal Injury']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes the interval between consecutive ESWL sessions affect the degree of renal injury?\n\nAre urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage?\n\nWhat is the optimal time interval between ESWL sessions to minimize renal injury?\n\nIf 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.\n\nParticipants will:\n\nUndergo ESWL treatment for urinary system stones\n\nBe assigned to one of two groups based on the time interval between ESWL sessions\n\nProvide urine samples before ESWL and after three ESWL sessions\n\nHave urinary NGAL and KIM-1 levels measured to assess renal injury'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease\n\nExclusion Criteria:\n\n* Positive nitrite on urinalysis prior to SWL\n* Positive urine culture prior to SWL, defined as \\>10⁵ CFU/mL bacterial growth\n* Suspected struvite stone, based on previous or partial stone analysis\n* Presence of a nephrostomy tube\n* Presence of urinary diversion\n* History of bleeding disorders\n* Pregnancy\n* Use of anticoagulant therapy\n* History of cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT07341269', 'briefTitle': 'Urinary NGAL and KIM-1 After ESWL', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MAR.UAD.0027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing extracorporeal shock wave lithotripsy (SWL)', 'interventionNames': ['Other: No Interventions', 'Other: No intervention']}], 'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'No study-specific intervention; patients receive standard-of-care SWL.', 'armGroupLabels': ['Patients undergoing extracorporeal shock wave lithotripsy (SWL)']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No study-specific intervention; patients receive standard-of-care SWL.', 'armGroupLabels': ['Patients undergoing extracorporeal shock wave lithotripsy (SWL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34854', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University School of Medicine Urology Department', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}