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Clinical Trials in the USA / NCT06982235
Active, not recruiting Observational

Stone and Laser Therapies Post-Market Study (SALT)

NCT06982235 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2025-06-30
Last updated
2026-09-14

Condition(s) studied

Benign Prostate Hypertrophy(BPH)Renal CalculiUreteral Stones, Kidney StonesCalculi, UrinaryUrinary Tract Procedure

Investigational drug(s) / intervention(s)

Ureteroscope systemLaser system

Ureteroscope system: LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring

Laser system: Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Mayo Clinic Phoenix Phoenix Arizona
University of Miami Hospital Miami Florida
University of South Florida Tampa Florida
Indiana University Medical Center Indianapolis Indiana
Duke University Medical Center Durham North Carolina

More Boston Scientific Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06982235 on ClinicalTrials.gov ↗ ← All trials in the USA