Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:13 AM
Study NCT ID:
NCT07349992
Status:
COMPLETED
Last Update Posted:
2026-01-20
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrograde Intrarenal Surgery (RIRS) With High-Power Laser and Flexible, Navigable Suction Access Sheath (FANS) vs Mini-Percutaneous Nephrolithotomy (miniPCNL) for 2-3 cm Renal Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone-Free Rate', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin change', 'timeFrame': 'postoperative first day'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'Perioperative'}, {'measure': 'Complications', 'timeFrame': 'up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Stones', 'Nephrolithiasis']}, 'descriptionModule': {'briefSummary': 'This prospective cohort study aims to compare the safety and efficacy of retrograde intrarenal surgery combined with a high-power Holmium:YAG laser and flexible navigable suction access sheath versus mini-percutaneous nephrolithotomy in patients with 2-3 cm renal stones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Kidney stones measuring 2-3 cm\n* Suitable for Retrograde Intrarenal Surgery (RIRS) or Mini-Percutaneous Nephrolithotomy (MiniPCNL)\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Renal transplantation\n* Congenital renal anomalies\n* Uncorrectable coagulopathy'}, 'identificationModule': {'nctId': 'NCT07349992', 'briefTitle': 'Retrograde Intrarenal Surgery (RIRS) With High-Power Laser and Flexible, Navigable Suction Access Sheath (FANS) vs Mini-Percutaneous Nephrolithotomy (miniPCNL) for 2-3 cm Renal Stones', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': 'Flexible Ureterorenoscopy With High-Power Holmium: YAG Laser and Flexible, Navigable Suction Access Sheath vs Mini-Percutaneous Nephrolithotomy in 2-3 cm Kidney Stones Treatment: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'RIRS-MiniPCNL-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retrograde Intrarenal Surgery (RIRS) Group', 'description': 'Intervention: Procedure-Retrograde Intrarenal Surgery', 'interventionNames': ['Procedure: Retrograde Intrarenal Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Mini-Percutaneous Nephrolithotomy (MiniPCNL) Group', 'description': 'Intervention: Procedure- Mini Percutaneous Nephrolithotomy', 'interventionNames': ['Procedure: Mini Percutaneous Nephrolithotomy']}], 'interventions': [{'name': 'Retrograde Intrarenal Surgery', 'type': 'PROCEDURE', 'description': 'We performed retrograde intrarenal surgery combined with a high-power Holmium:YAG laser and flexible navigable suction access sheath in patients with 2-3 cm renal stones.', 'armGroupLabels': ['Retrograde Intrarenal Surgery (RIRS) Group']}, {'name': 'Mini Percutaneous Nephrolithotomy', 'type': 'PROCEDURE', 'description': 'We performed mini-percutaneous nephrolithotomy in patients with 2-3 cm renal stones.', 'armGroupLabels': ['Mini-Percutaneous Nephrolithotomy (MiniPCNL) Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'state': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University Medical Faculty', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal Investigator', 'investigatorFullName': 'Muzaffer Tansel Kilinc', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}