Benign Prostate Hypertrophy(BPH), Calculi, Urinary, Renal Calculi, Ureteral Stones, Kidney Stones, Urinary Tract Procedure
Conditions
Keywords
BPH, Benign Prostatic Hyperplasia, Lithotripsy, Renal Calculi, Renal Calculus, Boston Scientific, Kidney Stone, Urinary Tract Procedure
Brief 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.
Detailed 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.
Interventions
DEVICEUreteroscope system
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
DEVICELaser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Serious Adverse Events related to BSC study devices | From procedure to 12-months after the procedure | The primary endpoint is the occurrence of serious adverse events related to BSC study devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Stone Free Rate in therapeutic Urinary Tract Procedures | 21 - 90 days after the procedure | For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study. |
| Change in BPH symptoms | 6 months after the procedure | In subjects with applicable benign prostatic hyperplasia (BPH) procedure(s): Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 6 months follow up, on a scale of 0 to 35. |
Countries
United States
Contacts
STUDY_DIRECTORGita Ghadimi, OD
Boston Scientific Corporation
Outcome results
None listed