Post-market monitoring of stone and laser devices for urinary tract and BPH procedures

Stone and Laser Therapies Post-Market Study

This project will test how Boston Scientific's ureteroscope and laser systems work and how safe they are in people having urinary tract procedures or BPH treatment, with follow-up for one year.

Quick facts

• Study type: Observational
• Enrollment: 238 (estimated)
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 5 sites (Phoenix, Arizona and 4 other locations)
• Trial ID: NCT06982235 on ClinicalTrials.gov

What this trial studies

The SALT study is a multi-center, open-label, non-randomized prospective observational registry collecting post-market safety and device performance data for Boston Scientific ureteroscope and laser systems used during diagnostic or therapeutic urinary tract procedures and surgical BPH treatment. Participants are enrolled into two cohorts: patients undergoing urinary tract procedures and men aged 40 or older undergoing BPH treatment, each when a qualified BSC device is planned for use. Enrolled subjects are followed for one year after the index procedure to capture device performance, adverse events, and routine clinical outcomes. The study does not randomize treatments and documents real-world device use across several U.S. academic centers.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled to undergo a diagnostic or therapeutic urinary tract procedure using Boston Scientific ureteroscope or laser systems, or men aged 40+ planning BPH treatment with those devices who can complete follow-up visits.

Not a fit: People who cannot consent, cannot complete follow-up, require simultaneous conflicting procedures (for example simultaneous BPH surgery in the urinary tract cohort or upper urinary tract lithotripsy in the BPH cohort), or have other conditions that preclude participation are unlikely to benefit.

Why it matters

Potential benefit: If successful, the study could reassure patients and clinicians about the real-world safety and reliability of these devices and help guide device selection.

How similar studies have performed: Ureteroscopes and surgical laser systems have established efficacy in prior clinical trials and registries, and post-market registries are commonly used to confirm safety and performance in routine practice.

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.)

Where this trial is running

Phoenix, Arizona and 4 other locations

• Mayo Clinic Phoenix — Phoenix, Arizona, United States (Recruiting)
• University of Miami Hospital — Miami, Florida, United States (Recruiting)
• University of South Florida — Tampa, Florida, United States (Recruiting)
• Indiana University Medical Center — Indianapolis, Indiana, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Winnie Chen

Conditions Benign Prostate Hypertrophy; Renal Calculi; Ureteral Stones, Kidney Stones; Calculi, Urinary; Urinary Tract Procedure; BPH; Benign Prostatic Hyperplasia; Lithotripsy