Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT06624306
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'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': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the prone with the prone-flexed position for PCNL reporting complications', 'timeFrame': '1 year', 'description': 'Outcome measures by using the clavien dindo classification system'}], 'secondaryOutcomes': [{'measure': 'Assessment of stone free rate of the two groups', 'timeFrame': '1 year', 'description': 'Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urolithiasis', 'Kidney Stone', 'Complication']}, 'descriptionModule': {'briefSummary': 'Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Staghorn calculi\n2. Renal pelvis stones \\>2 cm\n3. Lower pole stones \\>1.5 cm\n4. SWL-resistant stones\n\nExclusion Criteria:\n\n1. Age \\<18 years or Pregnancy\n2. Bilateral simultaneous PCNL\n3. Need for 3 percutaneous tracts intraoperative\n4. Morbid obesity (BMI \\>40)\n5. Non opaque renal stones.\n6. Refuse to complete study requirements\n7. Atypical bowel interposition need CT guided puncture\n8. Tumour in the presumptive access tract area or Potential malignant kidney tumour'}, 'identificationModule': {'nctId': 'NCT06624306', 'briefTitle': 'Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University Hospital'}, 'officialTitle': 'Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)', 'orgStudyIdInfo': {'id': 'PF-PCNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prone PNL', 'description': 'Prone PNL', 'interventionNames': ['Procedure: Prone PNL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prone-flexed PNL', 'description': 'prone-flexed PNL', 'interventionNames': ['Procedure: Prone-flexed PNL']}], 'interventions': [{'name': 'Prone PNL', 'type': 'PROCEDURE', 'description': 'Prone PNL', 'armGroupLabels': ['prone PNL']}, {'name': 'Prone-flexed PNL', 'type': 'PROCEDURE', 'description': 'Prone-flexed PNL', 'armGroupLabels': ['prone-flexed PNL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4558', 'city': 'Al Fayyum', 'state': 'Faiyum Governorate', 'country': 'Egypt', 'facility': 'Fayoum faculty of Medicine', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hesham Abdel Azim El Helaly', 'investigatorAffiliation': 'Fayoum University Hospital'}}}}