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NCT Number: NCT06982235

Stone and Laser Therapies Post-Market Study (SALT)

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.

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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Calculi Calculi, Urinary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Renal Calculi Ureteral Stones, Kidney Stones Urinary Calculi Urinary Tract Procedure Urogenital Diseases Urolithiasis Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Phoenix, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For urinary tract procedure cohort:

  • 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

For BPH cohort:

  • 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

For urinary tract procedure cohort:

  • 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.)

For BPH cohort:

  • 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.)

Treatment and study plan

Ureteroscope system

Device

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

Laser system

Device

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

Primary outcomes

  1. Occurrence of Serious Adverse Events related to BSC study devices

    Time frame: From procedure to 12-months after the procedure

    The primary endpoint is the occurrence of serious adverse events related to BSC study devices.

Secondary outcomes

  1. Assess Stone Free Rate in therapeutic Urinary Tract Procedures

    Time frame: 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.

  2. Change in BPH symptoms

    Time frame: 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.

Other outcomes

  1. Health status as measured by EQ-5D-5L

    Time frame: From baseline through post-procedure standard-of-care follow-up within 12 months of the index procedure

    Pre-and post-operative health status as measured by a validated quality-of-life questionnaire, the EQ-5D five-level (5L) (EQ-5D-5L).

    The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) to rate perceived health from 0 (worst imaginable health) to 100 (best imaginable health).

  2. Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort

    Time frame: From baseline to 6-weeks post procedure

    Pre- and post-operative pain as measured by validated pain questionnaire (Brief Pain Inventory).

  3. Change in uroflowmetry in BPH cohort

    Time frame: Baseline to 12-months after the procedure

    Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) within 12 months of index procedure

  4. Quality of Life for BPH cohort measured by Male Sexual Health Questionnaire (MSHQ)

    Time frame: Baseline to 12-months after the procedure

    Quality of Life for BPH cohort measured via a validated questionnaire, Male Sexual Health Questionnaire (MSHQ). Change in MHSQ score will be assessed. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Curtis Blackwell

CONTACT

952-930-6000

Winnie Chen

CONTACT

[email protected]

952-930-6000

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Stone and Laser Therapies Post-Market Study

Acronym: SALT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 21, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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