Stone and Laser Therapies Post-Market Study (SALT)

Not yet recruiting

• Conditions: Benign Prostate Hypertrophy(BPH); Renal Calculi; Ureteral Stones, Kidney Stones; Urinary Tract Procedure; Calculi, Urinary

• Registration Number: NCT06982235
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

The SALT study is a multi-center, open label, non-randomized, prospective observational study to document on-going post-market safety and device performance data of BSC commercially available study devices that are used in diagnostic and/or therapeutic urinary tract procedures or surgical treatment for BPH.

Enrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 238

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of Serious Adverse Events related to BSC study devices	From procedure to 12-months after the procedure	The primary endpoint is the occurrence of serious adverse events related to BSC study devices.

Secondary Outcome Measures

Name	Time	Method
Assess Stone Free Rate in therapeutic Urinary Tract Procedures	21 - 90 days after the procedure	For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study.
Change in BPH symptoms	6 months after the procedure	In subjects with applicable benign prostatic hyperplasia (BPH) procedure(s): Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 6 months follow up, on a scale of 0 to 35.