Stone and Laser Therapies Post-Market Study (SALT)

Boston Scientific

Status: Not yet enrolling

Conditions: Benign Prostate Hypertrophy(BPH); Calculi, Urinary; Urinary Tract Procedure; Ureteral Stones, Kidney Stones; Renal Calculi

Treatments: Device: Ureteroscope system; Device: Laser system

Study type: Observational

Funder types: Industry

Identifiers

NCT06982235

U0777

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

238 participants in 2 patient groups

Urinary Tract Procedure Cohort

Description:

Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)

Treatment:

Device: Laser system

Device: Ureteroscope system

Benign Prostatic Hyperplasia Cohort

Description:

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)

Treatment:

Device: Laser system