Stone and Laser Therapies Post-Market Study (SALT)

Launched by BOSTON SCIENTIFIC CORPORATION · May 19, 2025

Keywords

ClinConnect Summary

The SALT Study is looking at the safety and performance of specific medical devices made by Boston Scientific that are used for treating urinary tract issues, including kidney stones and benign prostatic hyperplasia (BPH), which is an enlargement of the prostate that can cause urinary problems. This study aims to gather important information after these devices have already been approved for use, to ensure they continue to work well and are safe for patients.

To participate in the study, you need to be at least 40 years old and have been diagnosed with BPH if you're joining the BPH group. If you're part of the urinary tract procedure group, you should plan to have a procedure using one of the study devices. All participants must be willing to attend follow-up visits after their procedure. However, if you need other surgeries at the same time or have certain medical issues, you may not be eligible. The study is not currently recruiting participants, but it’s an important step for ensuring the best care for patients using these treatments.

Gender

ALL

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.)