Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-15 @ 5:02 AM
Study NCT ID:
NCT01852669
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adjunct Inversion for Lower Pole Stone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shaun.lee@monash.edu', 'phone': '55145890', 'title': 'Dr Shaun Lee', 'organization': 'Monash University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Inversion, Hydration, ESWL', 'description': 'ESWL with hydration and inversion\n\nInversion: Patients inverted 30 degree head down in Trendelenburg position\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV', 'otherNumAtRisk': 71, 'otherNumAffected': 1, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ESWL, Hydration', 'description': 'ESWL with hydration\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV', 'otherNumAtRisk': 68, 'otherNumAffected': 2, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Are Stone Free at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inversion, Hydration, ESWL', 'description': 'ESWL with hydration and inversion\n\nInversion: Patients inverted 30 degree head down in Trendelenburg position\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}, {'id': 'OG001', 'title': 'ESWL, Hydration', 'description': 'ESWL with hydration\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inversion, Hydration, ESWL', 'description': 'ESWL with hydration and inversion\n\nInversion: Patients inverted 30 degree head down in Trendelenburg position\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}, {'id': 'FG001', 'title': 'ESWL, Hydration', 'description': 'ESWL with hydration\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'comment': 'Randomisation error. Patient has protocol violation which necessitated exclusion from analysis', 'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inversion, Hydration, ESWL', 'description': 'ESWL with hydration and inversion\n\nInversion: Patients inverted 30 degree head down in Trendelenburg position\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}, {'id': 'BG001', 'title': 'ESWL, Hydration', 'description': 'ESWL with hydration\n\nShock Wave Lithotripsy: Shock wave lithotripsy\n\nHydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '49.63', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2013-05-02', 'resultsFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2013-05-13', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-17', 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Are Stone Free at 3 Months', 'timeFrame': '3 months', 'description': 'To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Stone']}, 'referencesModule': {'references': [{'pmid': '24044912', 'type': 'DERIVED', 'citation': 'Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Solitary lower pole caliceal stone which is \\> 5 mm and \\< 20mm\n2. Not contraindicated for intravenous urogram (IVU) and subsequent X-rays\n3. Patient able to comply strictly with visits/medications\n4. Patient willing and agrees to enter study\n\nExclusion Criteria:\n\n1. Impaired function of the affected kidney\n2. Gross hydronephrosis of the affected kidney\n3. Associated distal obstruction\n4. Multiple stones\n5. Stone more than 2 cm in size\n6. Diverticular stone\n7. Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy\n8. Patients who are unable to tolerate the procedure\n9. Significant cardiac condition that does not allow the administration of force hydration or inversion.\n10. Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT01852669', 'briefTitle': 'Adjunct Inversion for Lower Pole Stone', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone', 'orgStudyIdInfo': {'id': 'LPS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inversion, Hydration, ESWL', 'description': 'ESWL with hydration and inversion', 'interventionNames': ['Procedure: Inversion', 'Procedure: Shock Wave Lithotripsy', 'Drug: Hydration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESWL, Hydration', 'description': 'ESWL with hydration', 'interventionNames': ['Procedure: Shock Wave Lithotripsy', 'Drug: Hydration']}], 'interventions': [{'name': 'Inversion', 'type': 'PROCEDURE', 'description': 'Patients inverted 30 degree head down in Trendelenburg position', 'armGroupLabels': ['Inversion, Hydration, ESWL']}, {'name': 'Shock Wave Lithotripsy', 'type': 'PROCEDURE', 'otherNames': ['ESWL'], 'description': 'Shock wave lithotripsy', 'armGroupLabels': ['ESWL, Hydration', 'Inversion, Hydration, ESWL']}, {'name': 'Hydration', 'type': 'DRUG', 'otherNames': ['Frusemide 20mg'], 'description': 'Hydration of patient with 0.5L NaCl and 20mg frusemide IV', 'armGroupLabels': ['ESWL, Hydration', 'Inversion, Hydration, ESWL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liong Men Long, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lam Wah Ee Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lam Wah Ee Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Shaun Lee Wen Huey', 'investigatorAffiliation': 'Monash University'}}}}