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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteroscope system | Device | LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Serious Adverse Events related to BSC study devices | The primary endpoint is the occurrence of serious adverse events related to BSC study devices. | From procedure to 12-months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Stone Free Rate in therapeutic Urinary Tract Procedures | For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study. | 21 - 90 days after the procedure |
| Change in BPH symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Health status as measured by EQ-5D-5L | Pre-and post-operative health status as measured by a validated quality-of-life questionnaire, the EQ-5D five-level (5L) (EQ-5D-5L). The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. Health state index scores generally range from less than 0 to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) to rate perceived health from 0 (worst imaginable health) to 100 (best imaginable health). |
Inclusion Criteria:
For urinary tract procedure cohort:
For BPH cohort:
Exclusion Criteria:
For urinary tract procedure cohort:
For BPH cohort:
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The SALT study will enroll subjects undergoing a diagnostic or therapeutic urinary tract procedure, or benign prostatic hyperplasia (BPH) procedure, using study devices. Subjects will generally be recruited from Investigators' practices. A minimum of 119 subjects will be enrolled in each cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Winnie Chen | Contact | 952-930-6000 | SALTregistry@bsci.com | |
| Curtis Blackwell | Contact | 952-930-6000 |
| Name | Affiliation | Role |
|---|---|---|
| Gita Ghadimi, OD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
Patient data is planned to be summarized in aggregate. Data listings of serious adverse events and any device deficiencies will be reported via anonymized code in clinical study reports as required per local regulations.
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D007669 | Kidney Calculi |
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Laser system | Device | Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology |
|
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.
| 6 months after the procedure |
| From baseline through post-procedure standard-of-care follow-up within 12 months of the index procedure |
| Pre- and post-operative pain assessment in Urinary Tract Procedure Cohort | Pre- and post-operative pain as measured by validated pain questionnaire (Brief Pain Inventory). | From baseline to 6-weeks post procedure |
| Change in uroflowmetry in BPH cohort | Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) within 12 months of index procedure | Baseline to 12-months after the procedure |
| Quality of Life for BPH cohort measured by Male Sexual Health Questionnaire (MSHQ) | Quality of Life for BPH cohort measured via a validated questionnaire, Male Sexual Health Questionnaire (MSHQ). Change in MHSQ score will be assessed. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes. | Baseline to 12-months after the procedure |
| University of Miami Hospital | Recruiting | Miami | Florida | 33442 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
|
| Indiana University Medical Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| D052801 |
| Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052878 | Urolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |