RecruitingNot Applicable

Stone and Laser Therapies Post-Market Study (SALT)

United States238 participantsStarted 2025-06-30

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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.)
✕. 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.)

What they're measuring

Occurrence of Serious Adverse Events related to BSC study devices

Timeframe: From procedure to 12-months after the procedure

Trial details

NCT IDNCT06982235

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-02

Contact for this trial

Winnie Chen

952-930-6000 SALTregistry@bsci.com

View on ClinicalTrials.gov More Benign Prostate Hypertrophy(BPH) trials