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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stone and Laser Therapies Post-Market Study
- ClinicalTrials.gov ID
- NCT06982235
- Acronym / sponsor ID
- SALT / U0777
- Conditions
- Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary, Urinary Tract Procedure
- Keywords
- BPH, Benign Prostatic Hyperplasia, Lithotripsy, Renal Calculi, Renal Calculus, Boston Scientific, Kidney Stone, Urinary Tract Procedure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Tract Procedure Cohort | – | Device: Ureteroscope system, Device: Laser systemSubjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s) |
| Benign Prostatic Hyperplasia Cohort | – | Device: Laser systemSubjects 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteroscope systemLithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring | Device | Urinary Tract Procedure Cohort |
| Laser systemPulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology | Device | Benign Prostatic Hyperplasia Cohort, Urinary Tract Procedure Cohort |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gita Ghadimi, OD study director
Boston Scientific Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH) and Renal Calculi, run by Boston Scientific Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Serious Adverse Events related to BSC study devices (time frame: From procedure to 12-months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.