Stone and Laser Therapies Post-Market Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Florida
University of Miami Hospital
RECRUITING
Miami
Indiana
Indiana University Medical Center
RECRUITING
Indianapolis
Contact Information
Primary
Winnie Chen
SALTregistry@bsci.com
952-930-6000
Backup
Curtis Blackwell
952-930-6000
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2029-02
Participants
Target number of participants: 238
Treatments
Urinary Tract Procedure Cohort
Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
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)
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov