Stone and Laser Therapies Post-Market Study SALT Study

M
Marcelino Rivera

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
119 participants needed
1 Location

Brief description of study

The purpose of this study is to obtain post-market safety and device performance data for qualified BSC Stone and BPH devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants who are identified as candidates for diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)urinary tract procedure will be approached or contacted by study team about study participation.  Enrollment is intended to be ongoing for this study. Enrollment for a specific device may continue throughout the device lifecycle as it is used in various combinations with existing or newly commercialized devices.

Detailed description of study

Multi-center, open label, non-randomized, prospective study to document on-going post-market safety and device performance of qualified BSC Stone and BPH devices, including (but not limited to) ureteroscopes, lasers, automated fluid management systems, and accessories.

All subjects meeting the enrollment criteria, signing the consent and undergoing a diagnostic and/or therapeutic urinary tract procedure or BPH treatment, with the study device(s) will be followed for 12 months post-procedure.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Urinary tract stone, Benign prostatic hyperplasia, BPH
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria:
For urinary tract procedure cohort:
1. Subject intends to undergo diagnostic and/or therapeutic urinary
tract procedure with qualified BSC device(s)
2. Subject is willing and able to complete all follow-up visits
 

For BPH cohort:
1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH)
with lower urinary tract symptoms
3. Subject intends to undergo BPH treatment with qualified BSC
device(s)
4. Subject is willing and able to complete all follow-up visits
 

Exclusion criteria:
For urinary tract procedure cohort:
1. Subject requires simultaneous surgical treatment for BPH
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator,
precludes study participation (e.g., history of medical non-
compliance, etc.)

For BPH cohort:
1. Subject requires simultaneous upper urinary calculi lithotripsy
procedure (not applicable to bladder calculi)
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator,
precludes study participation (e.g., history of medical non-
compliance, etc.)

Updated on 02 Sep 2025. Study ID: UROL-BOSTONSC-SALT, 26399
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only