Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT03526458
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2017-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lis@urology.wisc.edu', 'phone': '6082638336', 'title': 'Shuang Li', 'organization': 'University of Wisconsin, School of Medicine and Public Health, Department of Urology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 30 days of the surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fragmentation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.6', 'ciLowerLimit': '4.4', 'ciUpperLimit': '28.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 hours', 'description': 'The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '26.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 hours', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pre-Operative Stone Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '6.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Retrospective review of health chart at Baseline', 'description': 'Pre-operative stone size (on pre-operative CT) will be reported in millimeters.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Either Ureteral or Renal Location of Urinary Stone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'title': 'Ureteral', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Renal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 hours', 'description': 'Urinary stone location will be classified as renal or ureter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Treated for Either Single or Multiple Urinary Stones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'title': 'Single', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Density of Urinary Stones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'categories': [{'measurements': [{'value': '935.2', 'spread': '367.9', 'groupId': 'OG000'}, {'value': '924.7', 'spread': '374.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '-286', 'ciUpperLimit': '306.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '143.9', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 hours', 'unitOfMeasure': 'Hounsfield units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'OG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'classes': [{'title': '1mm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '2mm', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '3mm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 hours', 'description': 'Size of fragments created will be assessed using the laser fiber size as a comparison.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'FG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Surgeries rescheduled or cancelled due to COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Stone passed, surgery cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of equipment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Holmium:YAG Laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'BG001', 'title': 'Holmium:YAG Laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.\n\nHolmium:YAG laser: Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '53.6', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-30', 'size': 515077, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-27T15:03', 'hasProtocol': True}, {'date': '2017-09-27', 'size': 403598, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-15T17:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2017-11-14', 'resultsFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-27', 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fragmentation Time', 'timeFrame': 'up to 6 hours', 'description': 'The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)'}], 'secondaryOutcomes': [{'measure': 'Total Operative Time', 'timeFrame': 'up to 6 hours'}, {'measure': 'Pre-Operative Stone Size', 'timeFrame': 'Retrospective review of health chart at Baseline', 'description': 'Pre-operative stone size (on pre-operative CT) will be reported in millimeters.'}, {'measure': 'Number of Participants With Either Ureteral or Renal Location of Urinary Stone', 'timeFrame': 'up to 6 hours', 'description': 'Urinary stone location will be classified as renal or ureter.'}, {'measure': 'Number of Participants Treated for Either Single or Multiple Urinary Stones', 'timeFrame': 'up to 6 hours'}, {'measure': 'Density of Urinary Stones', 'timeFrame': 'up to 6 hours'}, {'measure': 'Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm', 'timeFrame': 'up to 6 hours', 'description': 'Size of fragments created will be assessed using the laser fiber size as a comparison.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Holmium Laser', 'Laser setting', 'Stone fragmentation'], 'conditions': ['Stone Ureter', 'Stone;Renal', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J\\&15Hz, and 0.8J\\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.', 'detailedDescription': "The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (\\<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (15Hz). Thus, the study contains two arms: 0.2J\\&15Hz, and 0.8J\\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.\n\nThe study procedures are:\n\n1. A study team member who is affiliated with the patient's clinical care (e.g., the surgeon) will initially approach the patients who are scheduled laser lithotripsy treatment of urinary stones. (i.e. informed that there's a research study they may be eligible for, and asked if they want to learn more about it).\n2. If the patient is interested in the study, a member of the research team will approach him/her for enrollment.\n3. Once the consent form is obtained, patients' medical background will be reviewed for inclusion/exclusion criteria. Patients who meet the inclusion criteria will be included in the study; patients who do not meet the inclusion criteria will be excluded.\n4. Patients will be randomized to either 0.2J\\&15Hz or 0.8J\\&15Hz (randomization ratio 1:1) group.\n5. Patients will undergo stone surgeries with the laser setting that they are randomized to. The patient's stone(s) will be treated in accordance with the routine clinical practice of fragmenting stone into small pieces (≤ 2mm). The faculty surgeon (i.e., Dr. Nakada) will perform all surgeries.\n6. Fragmentation time as well as other information (total surgery time, complications, stone information, and number of stones treated) is collected.\n7. After surgery, the patients will then continue on normal postoperative pathway. Postoperative complications will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 18 years of age\n* Patients with urinary stones who require endoscopic treatment\n\nExclusion Criteria:\n\n* Patients \\< 18 years of age\n* Pregnant patients\n* Pre-menopausal females who have not been on approved birth control for at least 1 month pre-operatively\n* Patients with stones known to be refractory to treatment with the holmium laser'}, 'identificationModule': {'nctId': 'NCT03526458', 'briefTitle': 'Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones', 'orgStudyIdInfo': {'id': '2017-0252'}, 'secondaryIdInfos': [{'id': 'A539800', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/UROLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 10/30/2017', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Holmium:YAG laser: 0.2J&15Hz', 'description': 'Patients are assigned to treat stones with 0.2J\\&15Hz of the holmium laser.', 'interventionNames': ['Device: Holmium:YAG laser']}, {'type': 'EXPERIMENTAL', 'label': 'Holmium:YAG laser: 0.8J&15Hz', 'description': 'Patients are assigned to treat stones with 0.8J\\&15Hz of the holmium laser.', 'interventionNames': ['Device: Holmium:YAG laser']}], 'interventions': [{'name': 'Holmium:YAG laser', 'type': 'DEVICE', 'description': 'Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)', 'armGroupLabels': ['Holmium:YAG laser: 0.2J&15Hz', 'Holmium:YAG laser: 0.8J&15Hz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Stephen Nakada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}