Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06384105
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Patient Radiation Dose During Five Endourological Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-06', 'size': 735146, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-22T15:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 870}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limit', 'timeFrame': '1 year', 'description': 'Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL'}], 'secondaryOutcomes': [{'measure': 'Difference in PRD', 'timeFrame': '1 year', 'description': 'Difference in the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL when the FPS are set to 3 to 5 compared to \\>5 to 8'}, {'measure': 'PRD different centres', 'timeFrame': '1 year', 'description': 'PRD differ between the different participating urologists and centres'}, {'measure': 'PRD difference complicated cases', 'timeFrame': '1 year', 'description': 'PRD difference between normal and complicated cases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Exposure', 'Urolithiasis']}, 'descriptionModule': {'briefSummary': 'In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.\n\nPurpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients who receive insertion/replacement of ureteral stent, URS (flexible or semirigid), (mini-)PCNL (including ECIRS) or ESWL under fluoroscopic with or without ultrasonic guidance\n* Only cases performed or directly supervised by experts\n\nExclusion Criteria:\n\n* Bilateral cases\n* Diagnostic ureterorenoscopies\n* Antegrade ureteroscopies\n* Procedures for Upper Tract Urothelial Carcinoma (UTUC)\n* Procedures on children (aged \\<18 years)\n* Pregnant women\n* Abnormal urinary anatomy (e.g. ureteral duplication, pelvic kidney, bladder derivation, horseshoe kidney)'}, 'identificationModule': {'nctId': 'NCT06384105', 'acronym': 'PRDE', 'briefTitle': 'Study of the Patient Radiation Dose During Five Endourological Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Prospective Multicentric Study of the Patient Radiation Dose During Five Endourological Procedures: Insertion and Replacement of Ureteral Stent, URS, (Mini-)PCNL/ PCNL and ESWL/SWL', 'orgStudyIdInfo': {'id': 'PRDE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FPS 3-5', 'description': 'Frames per second are set at 3-5 at the beginning of the procedure', 'interventionNames': ['Radiation: frames per second']}, {'type': 'EXPERIMENTAL', 'label': 'FPS >5-8', 'description': 'Frames per second are set at \\>5-8 at the beginning of the procedure', 'interventionNames': ['Radiation: frames per second']}], 'interventions': [{'name': 'frames per second', 'type': 'RADIATION', 'description': 'Other settings for frames per second', 'armGroupLabels': ['FPS 3-5', 'FPS >5-8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2930', 'city': 'Brasschaat', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Vincent De Coninck, MD', 'role': 'CONTACT', 'email': 'vincent.de.coninck@klina.be', 'phone': '+32 3 650 50 56', 'phoneExt': '+32'}], 'facility': 'AZ Klina', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Stefan De Wachter, MD', 'role': 'CONTACT', 'email': 'stefan.de.wachter@uza.be', 'phone': '+32 3 821 33 68', 'phoneExt': '+32'}], 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Vincent De Coninck, MD', 'role': 'CONTACT', 'email': 'vincent.de.coninck@klina.be', 'phone': '+32 3 650 50 56', 'phoneExt': '+32'}, {'name': 'Stefan De Wachter, MD', 'role': 'CONTACT', 'email': 'stefan.de.wachter@uza.be', 'phone': '+32 3 821 33 68', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Vincent De Coninck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be stored in RedCAP and will only be accessible by the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vincent De Coninck', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}