Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 1:20 AM
Study NCT ID:
NCT06982235
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stone and Laser Therapies Post-Market Study (SALT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D014545', 'term': 'Urinary Calculi'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health status as measured by EQ-5D-5L', 'timeFrame': 'From baseline through post-procedure standard-of-care follow-up within 12 months of the index procedure', 'description': 'Pre-and post-operative health status as measured by a validated quality-of-life questionnaire, the EQ-5D five-level (5L) (EQ-5D-5L).\n\nThe first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) to rate perceived health from 0 (worst imaginable health) to 100 (best imaginable health).'}, {'measure': 'Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort', 'timeFrame': 'From baseline to 6-weeks post procedure', 'description': 'Pre- and post-operative pain as measured by validated pain questionnaire (Brief Pain Inventory).'}, {'measure': 'Change in uroflowmetry in BPH cohort', 'timeFrame': 'Baseline to 12-months after the procedure', 'description': 'Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) within 12 months of index procedure'}, {'measure': 'Quality of Life for BPH cohort measured by Male Sexual Health Questionnaire (MSHQ)', 'timeFrame': 'Baseline to 12-months after the procedure', 'description': 'Quality of Life for BPH cohort measured via a validated questionnaire, Male Sexual Health Questionnaire (MSHQ). Change in MHSQ score will be assessed. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.'}], 'primaryOutcomes': [{'measure': 'Occurrence of Serious Adverse Events related to BSC study devices', 'timeFrame': 'From procedure to 12-months after the procedure', 'description': 'The primary endpoint is the occurrence of serious adverse events related to BSC study devices.'}], 'secondaryOutcomes': [{'measure': 'Assess Stone Free Rate in therapeutic Urinary Tract Procedures', 'timeFrame': '21 - 90 days after the procedure', 'description': 'For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study.'}, {'measure': 'Change in BPH symptoms', 'timeFrame': '6 months after the procedure', 'description': 'In subjects with applicable benign prostatic hyperplasia (BPH) procedure(s): Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 6 months follow up, on a scale of 0 to 35.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['BPH', 'Benign Prostatic Hyperplasia', 'Lithotripsy', 'Renal Calculi', 'Renal Calculus', 'Boston Scientific', 'Kidney Stone', 'Urinary Tract Procedure'], 'conditions': ['Benign Prostate Hypertrophy(BPH)', 'Renal Calculi', 'Ureteral Stones, Kidney Stones', 'Calculi, Urinary', 'Urinary Tract Procedure']}, 'descriptionModule': {'briefSummary': "The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.", 'detailedDescription': 'The SALT study is a multi-center, open label, non-randomized, prospective observational study to document on-going post-market safety and device performance data of BSC commercially available study devices that are used in diagnostic and/or therapeutic urinary tract procedures or surgical treatment for BPH.\n\nEnrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The SALT study will enroll subjects undergoing a diagnostic or therapeutic urinary tract procedure, or benign prostatic hyperplasia (BPH) procedure, using study devices. Subjects will generally be recruited from Investigators' practices. A minimum of 119 subjects will be enrolled in each cohort.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor urinary tract procedure cohort:\n\n1. Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)\n2. Subject is willing and able to complete all follow-up visits\n\nFor BPH cohort:\n\n1. Subject is ≥ 40 years of age\n2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms\n3. Subject intends to undergo BPH treatment with qualified BSC device(s)\n4. Subject is willing and able to complete all follow-up visits\n\nExclusion Criteria:\n\nFor urinary tract procedure cohort:\n\n1. Subject requires simultaneous surgical treatment for BPH\n2. Unwilling or unable to provide consent\n3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)\n\nFor BPH cohort:\n\n1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)\n2. Unwilling or unable to provide consent\n3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)'}, 'identificationModule': {'nctId': 'NCT06982235', 'acronym': 'SALT', 'briefTitle': 'Stone and Laser Therapies Post-Market Study (SALT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Stone and Laser Therapies Post-Market Study', 'orgStudyIdInfo': {'id': 'U0777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Urinary Tract Procedure Cohort', 'description': 'Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)', 'interventionNames': ['Device: Ureteroscope system', 'Device: Laser system']}, {'label': 'Benign Prostatic Hyperplasia Cohort', 'description': 'Subjects are at least 40 years of age diagnosed with BPH with lower urinary tract symptoms and intend to undergo BPH treatment with study device(s)', 'interventionNames': ['Device: Laser system']}], 'interventions': [{'name': 'Ureteroscope system', 'type': 'DEVICE', 'description': 'LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring', 'armGroupLabels': ['Urinary Tract Procedure Cohort']}, {'name': 'Laser system', 'type': 'DEVICE', 'description': 'Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology', 'armGroupLabels': ['Benign Prostatic Hyperplasia Cohort', 'Urinary Tract Procedure Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33442', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elena Cortez', 'role': 'CONTACT', 'email': 'ecortizas@med.miami.edu', 'phone': '305-216-0394'}, {'name': 'Hemendra Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ray De La Morena Quirch', 'role': 'CONTACT', 'email': 'rdelamorena@tgh.org', 'phone': '813-844-8824'}, {'name': 'Alexander Czachor', 'role': 'CONTACT', 'email': 'aczachor@tgh.org', 'phone': '813-660-7065'}, {'name': 'Hariharan Ganapathi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Wofford', 'role': 'CONTACT', 'email': 'sdwillia@iu.edu'}, {'name': 'Macelino Rivera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Schmidt', 'role': 'CONTACT', 'email': 'rebecca.schmidt@duke.edu', 'phone': '919-613-1178'}, {'name': 'Rohit Tejwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Winnie Chen', 'role': 'CONTACT', 'email': 'SALTregistry@bsci.com', 'phone': '952-930-6000'}, {'name': 'Curtis Blackwell', 'role': 'CONTACT', 'phone': '952-930-6000'}], 'overallOfficials': [{'name': 'Gita Ghadimi, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient data is planned to be summarized in aggregate. Data listings of serious adverse events and any device deficiencies will be reported via anonymized code in clinical study reports as required per local regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}