Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:58 AM
Study NCT ID:
NCT07328659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Our Study About Anew Technique to Improve Results of Peumatic Lithotripsy in Mimi Pcnl With Suction Sheath.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D052878', 'term': 'Urolithiasis'}], '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': '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group quasi interventional prospective study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone disintegration time', 'timeFrame': 'Day 1', 'description': 'Assesment of peumatic lithotripsy time during the operation.'}], 'secondaryOutcomes': [{'measure': 'Stone free rate', 'timeFrame': '-after the operation immediately and then after 1 month of the operation.', 'description': 'Presence of residual stones more than 3mm'}, {'measure': 'Rate of complications', 'timeFrame': 'Intraoperative and immediately post operative till one week.', 'description': 'rate of any intra or postoperative coplications.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urolithiasis', 'Endourology', 'Suction sheath'], 'conditions': ['Kidney Stone', 'Calculi, Renal']}, 'descriptionModule': {'briefSummary': 'Prospective study to assist safty and efficieny of our technique of using peumatic lithotripsy with suction mini-pcnl.', 'detailedDescription': 'anew techniqe was designed to improve the results of pneumatic lithotripsy in suction mini-PCNL by:\n\n1. Customize our instrument to be suitable for a short 12 Fr nephroscope.\n2. using certain measures to avoid stone migration during pneumatic disintegration.\n\nBy fixing stones during disintegration and suction.\n\n* Our puncture strategy was planned to prevent stone migration.\n* Use a suction sheath to gently fix the stone between the tip of the sheath and the inner wall of the kidney and disintegrate it from inside the sheath.\n* The dormai basket was used to fix the stone in front of the sheath in difficult situations.\n\nThe investigators will assess disintegration time as the primary endpoint and stone-free rate and complications as secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient with kidney stones less than 4 cm .\n\nExclusion Criteria:\n\n* children less than 3 yrs.\n* single kidney patient.\n* patient with ectopic kidney and spinal deformities.\n* unfit patient for surgry.'}, 'identificationModule': {'nctId': 'NCT07328659', 'briefTitle': 'Our Study About Anew Technique to Improve Results of Peumatic Lithotripsy in Mimi Pcnl With Suction Sheath.', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Our Stone Fixation Technique to Improve the Efficacy of Peumatic Lithotripsy With Suction Sheath in Mini-pcnl.', 'orgStudyIdInfo': {'id': 'RAD-MC-2025-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with kidney stones treated by our technique', 'description': 'Prospective assesment of results.', 'interventionNames': ['Procedure: Peumatic lithotripsy in mini-pcnl']}], 'interventions': [{'name': 'Peumatic lithotripsy in mini-pcnl', 'type': 'PROCEDURE', 'description': 'Using our technique to improve results of peumatic lithotripsy in suction mini-PCNL.', 'armGroupLabels': ['Patient with kidney stones treated by our technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'state': 'Aswan Governorate', 'country': 'Egypt', 'facility': 'Radar medical centre', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasser Gamil Elnagar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yasser Gamil Elnagar', 'investigatorAffiliation': 'Aswan University'}}}}