Stone and Laser Therapies Post-Market Study (SALT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ureteroscope system, Laser system.
- Who it may be relevant to
- Registry conditions: Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stone and Laser Therapies Post-Market Study
Overview
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.
Interventions
- Device Ureteroscope system
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring - Device Laser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Primary outcome measures
- Occurrence of Serious Adverse Events related to BSC study devices [Time frame: From procedure to 12-months after the procedure]
Secondary outcome measures (2)
- Assess Stone Free Rate in therapeutic Urinary Tract Procedures [Time frame: 21 - 90 days after the procedure]
- Change in BPH symptoms [Time frame: 6 months after the procedure]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Mayo Clinic Phoenix — Phoenix
- University of Miami Hospital — Miami
- University of South Florida — Tampa
- Indiana University Medical Center — Indianapolis
- Duke University Medical Center — Durham
Identifiers
NCT: NCT06982235 · U0777