Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
Study NCT ID:
NCT06797466
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-01-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with perioperative Bleeding.', 'timeFrame': 'immediately after the intervention/procedure/surgery'}, {'measure': 'Number of Participants with stone free', 'timeFrame': '1 month after the intervention/procedure/surgery'}, {'measure': 'leng of the hospital stay', 'timeFrame': 'immediately after the intervention/procedure/surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Complication', 'timeFrame': 'immediately after the intervention/procedure/surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PNL', 'Stone, Kidney']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with kidney stones larger than 2 cm and those with PCNL indication.\n\nExclusion Criteria:\n\n* Patients with missing CT images, missing clinical information, or inaccessible'}, 'identificationModule': {'nctId': 'NCT06797466', 'briefTitle': 'Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University'}, 'officialTitle': 'Investigation of the Effect of Three Dimensional Virtual Reconstruction (3D) on Percutaneous Nephrolithotomy Learning Curve in Specialist Training', 'orgStudyIdInfo': {'id': 'HRÜ/24.21.44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D imaging technique on the PCNL', 'interventionNames': ['Procedure: 3D imaging technique on the PCNL']}, {'type': 'NO_INTERVENTION', 'label': 'standard PCNL'}], 'interventions': [{'name': '3D imaging technique on the PCNL', 'type': 'PROCEDURE', 'description': 'Establishing a percutaneous access route for the stone is the first and most important step in PCNL surgery. Choosing the perfect route, position and direction largely depends on surgical experience and the ability to understand renal/peri-renal anatomy. In general, a good CT scan of the abdomen and pelvis and an experienced surgeon are sufficient, but this requires significant time in the learning curve. The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.', 'armGroupLabels': ['3D imaging technique on the PCNL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adıyaman', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ADIYAMAN EDUCATION AND RESEARCH HOSPITAL', 'role': 'CONTACT', 'email': 'adiyamaneah1@saglik.gov.tr', 'phone': '+90 416 216 10 15'}], 'facility': 'Adıyaman University', 'geoPoint': {'lat': 37.76441, 'lon': 38.27629}}], 'centralContacts': [{'name': 'Bedreddin Kalyenci, Doctor', 'role': 'CONTACT', 'email': 'bedreddin84@windowslive.com', 'phone': '+905554859583'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bedreddin Kalyenci', 'investigatorAffiliation': 'Adiyaman University'}}}}