Stone and Laser Therapies Post-Market Study (SALT)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston Scientific Corporation
Study ID
NCT06982235
Status
Recruiting
Apply to this trial

Conditions

  • Benign Prostate Hypertrophy(BPH)
  • Calculi, Urinary
  • Renal Calculi
  • Ureteral Stones, Kidney Stones
  • Urinary Tract Procedure

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ureteroscope system — DEVICE
    LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
  • Laser system — DEVICE
    Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
238 participants (estimated)

Arms

  • Arm: Urinary Tract Procedure Cohort
    Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
  • Arm: 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)

Primary Outcome Measure

Occurrence of Serious Adverse Events related to BSC study devices [ Time Frame: From procedure to 12-months after the procedure ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic PhoenixPhoenixArizona85054
Corbin Benson
[email protected]
Karen Stern, MD (PRINCIPAL_INVESTIGATOR)
University of Miami HospitalMiamiFlorida33442
Elena Cortez
[email protected]
305-216-0394
Hemendra Shah, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Ray De La Morena Quirch
[email protected]
813-844-8824
Alexander Czachor
[email protected]
813-660-7065
Hariharan Ganapathi, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Medical CenterIndianapolisIndiana46202
Stephanie Wofford
[email protected]
Macelino Rivera, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Rebecca Schmidt
[email protected]
919-613-1178
Rohit Tejwani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic Phoenix· Phoenix, AZUniversity of Miami Hospital· Miami, FLUniversity of South Florida· Tampa, FLIndiana University Medical Center· Indianapolis, INDuke University Medical Center· Durham, NC

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