Stone and Laser Therapies Post-Market Study (SALT)
SALT
1 other identifier
observational
238
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 21, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 15, 2026
April 1, 2026
3.6 years
April 30, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Serious Adverse Events related to BSC study devices
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
From procedure to 12-months after the procedure
Secondary Outcomes (2)
Assess Stone Free Rate in therapeutic Urinary Tract Procedures
21 - 90 days after the procedure
Change in BPH symptoms
6 months after the procedure
Other Outcomes (4)
Health status as measured by EQ-5D-5L
From baseline through post-procedure standard-of-care follow-up within 12 months of the index procedure
Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort
From baseline to 6-weeks post procedure
Change in uroflowmetry in BPH cohort
Baseline to 12-months after the procedure
- +1 more other outcomes
Study Arms (2)
Urinary Tract Procedure Cohort
Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
Benign Prostatic Hyperplasia Cohort
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)
Interventions
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Eligibility Criteria
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.
You may qualify if:
- For urinary tract procedure cohort:
- Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
- Subject is willing and able to complete all follow-up visits
- For BPH cohort:
- Subject is ≥ 40 years of age
- Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- Subject intends to undergo BPH treatment with qualified BSC device(s)
- Subject is willing and able to complete all follow-up visits
You may not qualify if:
- For urinary tract procedure cohort:
- Subject requires simultaneous surgical treatment for BPH
- Unwilling or unable to provide consent
- Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
- For BPH cohort:
- Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
- Unwilling or unable to provide consent
- Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
University of Miami Hospital
Miami, Florida, 33442, United States
University of South Florida
Tampa, Florida, 33606, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gita Ghadimi, OD
Boston Scientific Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 21, 2025
Study Start
June 30, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.