Stone and Laser Therapies Post-Market Study (SALT)
This study, called SALT, is looking at the safety and performance of two medical devices used for kidney stones, ureteral stones, and an enlarged prostate (Benign Prostate Hyperplasia or BPH). The devices are the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System and the Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology. Researchers want to see if there are any serious problems related to these devices up to 12 months after your procedure. You might be able to join if you are having a urinary tract procedure using these devices, or if you are at least 40 years old and have been diagnosed with BPH. The study aims to enroll 238 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information about how the devices are used in real-world settings. It is open-label, so both you and your doctors will know which devices are being used.
- What's involved
- If you join, you will undergo a diagnostic or therapeutic urinary tract procedure using the study devices. You will need to complete all follow-up visits after your procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after their procedure to monitor for any serious adverse events related to the study devices.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Stone and Laser Therapies Post-Market Study (SALT)
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Gita Ghadimi, OD · STUDY_DIRECTOR · Boston Scientific Corporation
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Occurrence of Serious Adverse Events related to BSC study devicesFrom procedure to 12-months after the procedure
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.