Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT03795532
Status:
UNKNOWN
Last Update Posted:
2019-01-23
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-20', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-01-04', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': '3 months following last session of SWL', 'description': 'Complete clearance of stones in addition to clinically insignificant residual fragments'}], 'secondaryOutcomes': [{'measure': 'Complications rate', 'timeFrame': '3 months following last session of SWL', 'description': 'Comparison of rate of complications in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal stones', 'SWL', 'High density stones', 'Ultraslow SWL', 'Slow SWL', 'Ramping', 'Pause'], 'conditions': ['Renal Stones']}, 'descriptionModule': {'briefSummary': 'Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value', 'detailedDescription': 'To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)\n* radio-opaque stone\n* high attenuation value (≥ 1000 HU) stone\n\nExclusion Criteria:\n\n* Abnormal renal anatomy\n* renal insufficiency\n* solitary kidney\n* coagulopathies\n* uncontrolled hypertension\n* renal artery or aortic aneurysm\n* active urinary tract infection\n* pregnancy\n* severe skeletal malformations (spinal deformity) precluding proper stone localization\n* skin to stone distance (SSD) \\> 11 cm\n* BMI \\> 30 Kgm/m2'}, 'identificationModule': {'nctId': 'NCT03795532', 'acronym': 'ESWL', 'briefTitle': 'Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultraslow Full-power SWL Versus Slow SWL in Renal Stones With High Attenuation Value', 'orgStudyIdInfo': {'id': '16224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultraslow shock wave lithotripsy (SWL)', 'description': 'SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power).', 'interventionNames': ['Procedure: SWL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Slow power-ramping SWL', 'description': 'SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.', 'interventionNames': ['Procedure: SWL']}], 'interventions': [{'name': 'SWL', 'type': 'PROCEDURE', 'otherNames': ['ESWL'], 'description': 'Shock wave lithotripsy', 'armGroupLabels': ['Slow power-ramping SWL', 'Ultraslow shock wave lithotripsy (SWL)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'state': 'Outside U.S./Canada', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'A AlDessoukey, Ass. Prof.', 'role': 'CONTACT'}, {'name': 'Mohammed S ElSheemy, A Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beni-Suef Hospitals', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Mohammed S ElSheemy, Ass. Prof.', 'role': 'CONTACT', 'email': 'mohammedshemy@yahoo.com', 'phone': '01006117755'}, {'name': 'Ahmad Aref Al-Dessoukey, Ass. Prof.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ahmad Aref Al-Dessoukey', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beni-Suef University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Urology', 'investigatorFullName': 'Mohammed Said ElSheemy', 'investigatorAffiliation': 'Cairo University'}}}}