Benign Prostate Hypertrophy(BPH)SALTNCT06982235
Stone and Laser Therapies Post-Market Study (SALT)
An observational study of Benign Prostate Hypertrophy(BPH) and Renal Calculi, run by Boston Scientific Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones
- What is being tested?
- Ureteroscope system and Laser system
- Type of treatment
- Medical device
- How many people
- 238 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2025to Feb 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The SALT study will enroll subjects undergoing a diagnostic or therapeutic urinary tract procedure, or benign prostatic hyperplasia (BPH) procedure, using study devices. Subjects will generally be recruited from Investigators' practices. A minimum of 119 subjects will be enrolled in each cohort.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Miami Hospital
Miami, Florida, 33442
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Stone and Laser Therapies Post-Market Study
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.
Read the 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.
- Conditions
- Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary, Urinary Tract Procedure
- Being tested
- Ureteroscope system, Laser system
- Keywords
- BPH, Benign Prostatic Hyperplasia, Lithotripsy, Renal Calculi, Renal Calculus, Boston Scientific, Kidney Stone, Urinary Tract Procedure
- Medical subject headings
- Prostatic Hyperplasia, Kidney Calculi, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscope systemDevice
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Laser systemDevice
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
| Study group | Role | What they receive |
|---|---|---|
| Urinary Tract Procedure Cohort | Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s) Receives: Device: Ureteroscope system; Device: Laser system | |
| Benign Prostatic Hyperplasia Cohort | Subjects are at least 40 years of age diagnosed with BPH with lower urinary tract symptoms and intend to undergo BPH treatment with study device(s) Receives: Device: Laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Serious Adverse Events related to BSC study devices
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
Measured: From procedure to 12-months after the procedure
Secondary outcomes (2)
Assess Stone Free Rate in therapeutic Urinary Tract Procedures
For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study.
Measured: 21 - 90 days after the procedure
Change in BPH symptoms
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.
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 Jun 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 238 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gita Ghadimi, OD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982235
- Sponsor's protocol ID
- U0777
- Acronym
- SALT
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patient data is planned to be summarized in aggregate. Data listings of serious adverse events and any device deficiencies will be reported via anonymized code in clinical study reports as required per local regulations.