Clinical trial NCT06982235: Stone and Laser Therapies Post-Market Study (SALT)
Official title: Stone and Laser Therapies Post-Market Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Benign Prostate Hypertrophy(BPH)
Renal Calculi
Ureteral Stones, Kidney Stones
Calculi, Urinary
Urinary Tract Procedure
Keywords: BPH
Benign Prostatic Hyperplasia
Lithotripsy
Renal Calculi
Renal Calculus
Boston Scientific
Kidney Stone
Urinary Tract Procedure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 238
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Enrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.

Eligibility criteria: Inclusion Criteria:

For urinary tract procedure cohort:

1. Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
2. Subject is willing and able to complete all follow-up visits

For BPH cohort:

1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
3. Subject intends to undergo BPH treatment with qualified BSC device(s)
4. Subject is willing and able to complete all follow-up visits

Exclusion Criteria:

For urinary tract procedure cohort:

1. Subject requires simultaneous surgical treatment for BPH
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)

For BPH cohort:

1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)

Primary outcomes:
measure: Occurrence of Serious Adverse Events related to BSC study devices
timeFrame: From procedure to 12-months after the procedure
Secondary outcomes:
measure: Assess Stone Free Rate in therapeutic Urinary Tract Procedures
timeFrame: 21 - 90 days after the procedure
measure: Change in BPH symptoms
timeFrame: 6 months after the procedure
Other outcomes:
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
measure: Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort
timeFrame: From baseline to 6-weeks post procedure
measure: Change in uroflowmetry in BPH cohort
timeFrame: Baseline to 12-months after the procedure
measure: Quality of Life for BPH cohort measured by Male Sexual Health Questionnaire (MSHQ)
timeFrame: Baseline to 12-months after the procedure
Locations:
Study officials:
References: