Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-17 @ 4:28 PM
Study NCT ID:
NCT03147950
Status:
UNKNOWN
Last Update Posted:
2017-06-07
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', '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 (SFR) of the two groups', 'timeFrame': '1 year', 'description': 'Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)'}, {'measure': 'Asses the easiness of accessibility of the targeted stone', 'timeFrame': '1 year', 'description': 'Outcome measures by counting number and site of puncture trial'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prone-Flexed Position', 'Percutaneous Nephrolithotomy (PCNL)', 'Clavien-Dindo Classification Score'], 'conditions': ['Percutaneous Nephrolithotomy (PCNL)', 'Prone Position', 'Prone-Flexed Position', 'Complication of Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Large renal pelvic stone\n* Upper calyceal stone\n* Middle calyceal stone\n\nExclusion Criteria:\n\n* lower calyceal stone\n* Bilateral simultaneous PCNL\n* Need for 3 percutaneous tracts intraoperative\n* Morbid obesity (BMI \\>40)\n* Non opaque renal stones.\n* Refuse to complete study requirements'}, 'identificationModule': {'nctId': 'NCT03147950', 'briefTitle': 'Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'F-Prone PNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prone-Flexed PCNL', 'description': 'Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)', 'interventionNames': ['Procedure: Prone-Flexed PCNL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prone PCNL', 'description': 'Prone Position For Percutaneous Nephrolithotomy (PCNL)', 'interventionNames': ['Procedure: Prone PCNL']}], 'interventions': [{'name': 'Prone-Flexed PCNL', 'type': 'PROCEDURE', 'otherNames': ['Prone-Flexed Percutaneous Nephrolithotomy'], 'description': 'Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)', 'armGroupLabels': ['Prone-Flexed PCNL']}, {'name': 'Prone PCNL', 'type': 'PROCEDURE', 'otherNames': ['Prone Percutaneous Nephrolithotomy'], 'description': 'Prone Position For Percutaneous Nephrolithotomy (PCNL)', 'armGroupLabels': ['Prone PCNL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Abdelwahab R. Hashem, Msc', 'role': 'CONTACT', 'email': 'abdelwahab_hashem@yahoo.com', 'phone': '01069678979', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Ahmed Shoma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Ahmed Elassmy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Nasr Eltabey, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Mohamed Zahran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Mahmoud Laimon, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Hossam Nabeeh, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Mohamed Abdulatif, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator', 'investigatorFullName': 'Abdelwahab Hashem', 'investigatorAffiliation': 'Mansoura University'}}}}