Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 11:48 AM
Study NCT ID:
NCT05808257
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thulium vs. Hol:YAG Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mantu.gupta@mountsinai.org', 'phone': '212-241-1272', 'title': 'Dr. Mantu Gupta', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 12 weeks postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Stone Free Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'OG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-12 weeks postoperative', 'description': 'Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fragmentation Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'OG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.46'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.', 'unitOfMeasure': 'mm3/sec', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lasing Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'OG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '39.6', 'upperLimit': '67.3'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '36.3', 'upperLimit': '55.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.', 'unitOfMeasure': 'percent of time using laser', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Energy Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'OG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '22.3'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '38.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.', 'unitOfMeasure': 'J/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'FG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)\n\nThulium Fibre Laser: The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.'}, {'id': 'BG001', 'title': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser\n\nHolmium:Yttrium-Aluminum-Garnet: The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'BG000', 'lowerLimit': '52.3', 'upperLimit': '69.8'}, {'value': '60.0', 'groupId': 'BG001', 'lowerLimit': '45.5', 'upperLimit': '72.0'}, {'value': '60.5', 'groupId': 'BG002', 'lowerLimit': '48.0', 'upperLimit': '69.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', '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': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', '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': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'BG000', 'lowerLimit': '24.8', 'upperLimit': '31.5'}, {'value': '26.6', 'groupId': 'BG001', 'lowerLimit': '23.4', 'upperLimit': '28.6'}, {'value': '26.8', 'groupId': 'BG002', 'lowerLimit': '24.7', 'upperLimit': '29.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-01', 'size': 420663, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-06T11:07', 'hasProtocol': True}, {'date': '2023-11-07', 'size': 368634, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-06T11:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2023-03-29', 'resultsFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-06', 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Stone Free Status', 'timeFrame': '6-12 weeks postoperative', 'description': 'Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy'}], 'secondaryOutcomes': [{'measure': 'Fragmentation Speed', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.'}, {'measure': 'Lasing Activity', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.'}, {'measure': 'Energy Utilization', 'timeFrame': 'Intraoperatively (Day 1)', 'description': 'Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nephrolithiasis']}, 'descriptionModule': {'briefSummary': 'This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:\n\n1. A superpulsed thulium fiber laser (thulium)\n2. A pulse modulated high power holmium laser (Holmium)', 'detailedDescription': 'This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:\n\n1. A superpulsed thulium fiber laser (thulium)\n2. A pulse modulated high power holmium laser (Holmium)\n\nThe researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between \\>5mm to \\< 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.\n\nAll subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.\n\nThe primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Undergoing single stage unilateral RIRS for total stone burden volume \\>5mm to \\< 20 mm\n* Preoperative CT scan for baseline measurements\n\nExclusion criteria:\n\n* Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture\n* Ureteral stent\n* Uric acid component \\>50% on stone analysis\n* Prior ureteroscopy within 6 weeks of current surgery\n* Irreversible coagulopathy\n* Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.'}, 'identificationModule': {'nctId': 'NCT05808257', 'briefTitle': 'Thulium vs. Hol:YAG Laser', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery', 'orgStudyIdInfo': {'id': 'STUDY-22-01521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thulium Fibre Laser (TFL)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)', 'interventionNames': ['Device: Thulium Fibre Laser']}, {'type': 'EXPERIMENTAL', 'label': 'Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)', 'description': 'Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser', 'interventionNames': ['Device: Holmium:Yttrium-Aluminum-Garnet']}], 'interventions': [{'name': 'Thulium Fibre Laser', 'type': 'DEVICE', 'otherNames': ['TFL'], 'description': 'The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.', 'armGroupLabels': ['Thulium Fibre Laser (TFL)']}, {'name': 'Holmium:Yttrium-Aluminum-Garnet', 'type': 'DEVICE', 'otherNames': ['Ho:YAG'], 'description': 'The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.', 'armGroupLabels': ['Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai West', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mantu Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Mantu Gupta', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}