Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02683993
Status:
COMPLETED
Last Update Posted:
2025-11-07
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'teri.bird@bsci.com', 'phone': '6123221189', 'title': 'Teri Bird', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Intra-operative to 1 month post-procedure', 'description': 'Adverse event information was collected via assessments at follow-up visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding', 'notes': 'Occasional hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'notes': 'minimal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stone Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Complete clearance', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Evidence of fragments not requiring intervention', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Evidence of fragments requiring an additional intervention', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Stone clearance based on 1 month follow-up imaging data', 'description': 'stone clearance will be confirmed by CT or X-Ray at 1 month follow up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-procedure Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Ureteric catheter not placed at the end of procedure', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Ureteric catheter placed at the end of procedure and not removed at hospital discharge', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure', 'description': 'Post-procedure catheterization by group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the procedure', 'description': 'Duration (in minutes) of the procedure as an indicator for treatment efficiency.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Usage of Alternative Stone Extracting Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Any alternate stone extracting devices used', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'No alternate stone extracting devices used', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'as measured during the procedure', 'description': 'The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Same day hospital discharge', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Next day hospital discharge', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure through hospital discharge', 'description': 'Hospital duration was measured to evaluate treatment efficiency', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intraoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Number of participants with complications that occur during the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visibility During Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very Good', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraprocedural', 'description': 'Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Retropulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Did not occur', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Occurred several times but could be controlled', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Occurred several times and was difficult to control', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stone lost to retropulsion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Occurrence of retropulsion by group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ability to Reach Stone Fragments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Easily performed', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Performed well', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Performed with difficulty', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Impossible to perform', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Performance rating of ability to reach stone fragments by group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Damage to Scope or Fiber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'title': 'Scope damage', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Fiber damage', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Damage to scope or fiber by group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fiber Transmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'OG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'classes': [{'categories': [{'title': 'Easily performed', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Performed well', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Performed with difficulty', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Impossible to perform', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Fiber transmission (preserving energy transmission during lasing) by group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'FG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stone Breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'BG001', 'title': 'Stone Dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.\n\nLumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.2', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-28', 'size': 788306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-26T16:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2016-01-28', 'resultsFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-23', 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone Clearance', 'timeFrame': 'Stone clearance based on 1 month follow-up imaging data', 'description': 'stone clearance will be confirmed by CT or X-Ray at 1 month follow up.'}, {'measure': 'Post-procedure Catheterization', 'timeFrame': 'Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure', 'description': 'Post-procedure catheterization by group'}, {'measure': 'Procedure Time', 'timeFrame': 'during the procedure', 'description': 'Duration (in minutes) of the procedure as an indicator for treatment efficiency.'}, {'measure': 'Usage of Alternative Stone Extracting Devices', 'timeFrame': 'as measured during the procedure', 'description': 'The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.'}, {'measure': 'Hospital Stay', 'timeFrame': 'Procedure through hospital discharge', 'description': 'Hospital duration was measured to evaluate treatment efficiency'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Intraoperative Complications', 'timeFrame': 'Intraoperative', 'description': 'Number of participants with complications that occur during the procedure.'}, {'measure': 'Visibility During Procedure', 'timeFrame': 'Intraprocedural', 'description': 'Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent'}, {'measure': 'Number of Participants With Occurrence of Retropulsion', 'timeFrame': 'Intraoperative', 'description': 'Occurrence of retropulsion by group'}, {'measure': 'Ability to Reach Stone Fragments', 'timeFrame': 'Intraoperative', 'description': 'Performance rating of ability to reach stone fragments by group'}, {'measure': 'Damage to Scope or Fiber', 'timeFrame': 'Intraoperative', 'description': 'Damage to scope or fiber by group'}, {'measure': 'Fiber Transmission', 'timeFrame': 'Intraoperative', 'description': 'Fiber transmission (preserving energy transmission during lasing) by group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stone Clearance']}, 'descriptionModule': {'briefSummary': 'Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.', 'detailedDescription': 'This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject will be older than 18 years of age\n2. Subject was diagnosed with renal calculi meeting the following criteria:\n\n * Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.\n * Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.\n3. Subject is a candidate for FURS procedure\n4. Subject is willing and has signed the Informed Consent Form\n\nExclusion Criteria:\n\n1. Subject has undergone a previous treatment for stones in the same kidney\n2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.\n3. Female subject is pregnant\n4. Concomitant anticoagulant medication that cannot be suspended during surgery'}, 'identificationModule': {'nctId': 'NCT02683993', 'briefTitle': 'Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings', 'orgStudyIdInfo': {'id': 'LUM-SBU-VP-15-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stone breaking', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.', 'interventionNames': ['Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber']}, {'type': 'EXPERIMENTAL', 'label': 'Stone dusting', 'description': 'Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.', 'interventionNames': ['Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber']}], 'interventions': [{'name': 'Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber', 'type': 'DEVICE', 'description': 'The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.', 'armGroupLabels': ['Stone breaking', 'Stone dusting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11215', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Methodist Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lumenis Be Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}