Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-04 @ 11:56 AM
Study NCT ID:
NCT06120257
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2023-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Lower Pole Renal Hard Stones ≤2 cm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008096', 'term': 'Lithotripsy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': 'after two weeks from primary procedure', 'description': 'no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.'}], 'secondaryOutcomes': [{'measure': 'assess operative time.', 'timeFrame': 'during the procedure', 'description': 'assess operative time.in minutes'}, {'measure': 'visual analog scale', 'timeFrame': 'immediately after the surgery', 'description': "Patient self dependent to assess degree of own pain, consists of a 10cm line, with two end points representing 0 minimum score('no pain') and 10 maximum score('pain as bad as it could possibly be').higher scores mean a worse outcome."}, {'measure': 'Radiation time', 'timeFrame': 'during the procedure', 'description': 'Time of patient exposure for radiation in minutes'}, {'measure': 'Post operative complication', 'timeFrame': 'Up to 48 hours', 'description': 'Complication may occur post operative complication like fever, sever pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hard stones'], 'conditions': ['Renal Stones']}, 'referencesModule': {'references': [{'pmid': '39736616', 'type': 'DERIVED', 'citation': 'Zeinelabden KM, Abdelhalim E, Galal M, Abdelbaky T, Nabeeh H. Flexible ureteroscopy, extracorporeal shock wave lithotripsy and mini percutaneous nephrolithotomy for management of lower pole renal hard stones </= 2 cm: a prospective randomized study. BMC Urol. 2024 Dec 30;24(1):288. doi: 10.1186/s12894-024-01644-z.'}]}, 'descriptionModule': {'briefSummary': 'The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient older than 18 years.\n* single renal stone.\n* medium sized Stone up to 2.0 cm .\n* Do novo\n* Stone in lower calyceal stone\n* Hard stone\n\nExclusion Criteria:\n\n* • multiple renal stones\n\n * stone size \\> 2 cm\n * age group \\< 18\n * solitary kidney\n * Patients with BMI \\> 40 kg/m2\n * bleeding disorders\n * anatomical renal abnormalities\n * Obstruction distal to the stone.\n * Musculoskeletal deformities'}, 'identificationModule': {'nctId': 'NCT06120257', 'briefTitle': 'Management of Lower Pole Renal Hard Stones ≤2 cm', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study', 'orgStudyIdInfo': {'id': 'KFSIRB200-69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A :Flexible ureteroscope group', 'description': 'Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)', 'interventionNames': ['Procedure: lithotripsy using Flexible ureteroscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B : extracorporeal shock wave lithotripsy (ESWL) group', 'description': 'extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)', 'interventionNames': ['Procedure: extracorporeal shock wave lithotripsy (ESWL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C : Mini perc group', 'description': 'Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.', 'interventionNames': ['Procedure: holmium laser lithotripsy using Karl® Storz MIP set']}], 'interventions': [{'name': 'lithotripsy using Flexible ureteroscope', 'type': 'PROCEDURE', 'description': 'using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate', 'armGroupLabels': ['Group A :Flexible ureteroscope group']}, {'name': 'extracorporeal shock wave lithotripsy (ESWL)', 'type': 'PROCEDURE', 'description': 'using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate', 'armGroupLabels': ['Group B : extracorporeal shock wave lithotripsy (ESWL) group']}, {'name': 'holmium laser lithotripsy using Karl® Storz MIP set', 'type': 'PROCEDURE', 'description': 'using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate', 'armGroupLabels': ['Group C : Mini perc group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Kafrelsheikh University hospital', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsayed Abdelhalim Elsayed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elsayed Abdelhalim Elsayed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}