Stone and Laser Therapies Post-Market Study (SALT) (SALT)

Stone and Laser Therapies Post-Market Study

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Calculi; Calculi, Urinary; Ureteral Stones, Kidney Stones; Benign Prostate Hypertrophy(BPH); Urinary Tract Procedure
• Intervention / Treatment: Device: Ureteroscope system; Device: Laser system

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.

• Study Type: Observational
• Enrollment (Estimated): 238

Contacts and Locations

• Study Contact: Name: Winnie Chen; Phone Number: 952-930-6000; Email: SALTregistry@bsci.com
• Study Contact Backup: Name: Curtis Blackwell; Phone Number: 952-930-6000

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Phoenix
      • Contact: Corbin Benson; Email: benson.corbin@mayo.edu
      • Principal Investigator: Karen Stern, MD
  • Florida
    • Miami, Florida, United States, 33442
      • Recruiting
      • University of Miami Hospital
      • Principal Investigator: Hemendra Shah, MD
      • Contact: Elena Cortez; Phone Number: 305-216-0394; Email: ecortizas@med.miami.edu
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Contact: Ray De La Morena Quirch; Phone Number: 813-844-8824; Email: rdelamorena@tgh.org
      • Contact: Alexander Czachor; Phone Number: 813-660-7065; Email: aczachor@tgh.org
      • Principal Investigator: Hariharan Ganapathi, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Medical Center
      • Contact: Stephanie Wofford; Email: sdwillia@iu.edu
      • Principal Investigator: Macelino Rivera, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Rebecca Schmidt; Phone Number: 919-613-1178; Email: rebecca.schmidt@duke.edu
      • Principal Investigator: Rohit Tejwani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urinary Tract Procedure Cohort; Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)	Device: Ureteroscope system; LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring; Device: Laser system; Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
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)	Device: Laser system; Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Gita Ghadimi, OD, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: April 30, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Lithotripsy; BPH; Renal Calculi; Boston Scientific; Kidney Stone; Renal Calculus; Urinary Tract Procedure
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Prostatic Hyperplasia; Urinary Calculi
• Other Study ID Numbers: U0777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No