LithoVue Elite Registry (LVE)

LithoVue Elite (LVE) Registry

To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.

Study Overview

• Status: Withdrawn
• Conditions: Urolithiasis; Kidney Stone
• Intervention / Treatment: Device: LithoVue Elite System

Detailed Description

LithoVue Elite Registry is a post-market, multi-center, open label, non-randomized, prospective study to document the safety and efficacy data on Boston Scientific LithoVue™ Elite System.

LithoVue Elite System, includes the StoneSmart™ Connect Console (reusable capital/workstation) and a single-use, disposable ureteroscope device.

The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

This is a post-market registry study. Any subject who meets eligibility criteria, intends to undergo a diagnostic and/or therapeutic procedure utilizing the LithoVue Elite System, and is willing to provide written informed consent, will be approached and considered for enrollment in the study. Data from diagnostic/therapeutic ureteroscopy procedure and standard of care post-ureteroscopy follow-up visits will be collected. These standard of care follow-up visits are expected to be scheduled within 120 days of the ureteroscopic procedure.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Up to 250 subjects will be enrolled at approximately 11 sites globally

Description

Inclusion Criteria:

1. Subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with Boston Scientific LithoVue Elite System
2. Subject is able to accurately detect and report pain
3. Subject is willing and able to complete subject questionnaire at specified time points
4. Subject is willing and able to return for all follow-up visits

Exclusion Criteria:

1. Subject meets any of the contraindications per LithoVue Elite System Instructions/Directions for Use (IFU/DFU)
2. Subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure
3. Investigator deems subject not suitable for the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pressure Monitoring; Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite pressure monitoring single use flexible scope, real-time pressure monitoring technology, which will provide surgeons with intraluminal pressure data in the kidneys and ureter.	Device: LithoVue Elite System; The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Non-Pressure Monitoring; Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope.	Device: LithoVue Elite System; The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint	Primary safety end point is the occurrence of Serious Adverse Device Effects (SADE) related to the LithoVue Elite System including, but not limited to urinary tract perforation and ureteral avulsion	Up to 120 days of follow up
Technical Success using LithoVue Elite System - Primary Effectiveness Endpoint	Primary effectiveness endpoint is the technical success using LithoVue Elite System, defined as: Scope allows access to intended urinary anatomy (including utilization of active deflection and guidewire or access sheath); Scope allows diagnostic and therapeutic tools, as identified in product labelling, to be utilized at target area, if applicable; Scope provides sufficient imaging for target visualization, (stone, calyx, etc.); Scope provides real-time urinary system pressure measurements at target sites, if applicable Tool used will be a yes or no question on the case report form	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint	Secondary safety endpoint is the occurrence of Procedure-related adverse events and/or adverse device effects related to the LithoVue Elite System	Up to 120 days of follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone Free Rate - Additional Endpoint	Stone clearance assessed by stone free rates (SFR), if applicable, at the follow-up visit	Up to 120 days of follow up
Surgeon Satisfaction with use of Scope - Additional Endpoint	Surgeon satisfaction on the use of scope will be measured on a 1-5 Likert scale	Procedure
Post-operative Pain (Brief Pain Inventory (BPI)) - Additional Endpoint	Pain intensity and pain interference score on a scale of 0 to 10 as measured on the BPI	Discharge, 7 days post procedure and 30 days post procedure
Post-operative Infection - Additional Endpoint	Post-operative infection within 30 days of the procedure	Up to 30 days post procedure
Post-operative Systemic Inflammatory Response Syndrome (SIRS) - Additional Endpoint	In subjects hospitalized post-procedure for infection, the complication will be characterized using the clinical measurements of the Systemic Inflammatory Response Syndrome (SIRS) score, if available. Subjects with a score ≥2 points meet the SIRS criteria	Up to 30 days post procedure
Post-operative Quick Sepsis Related Organ Failure Assessment (qSOFA) - Additional Endpoint	In subjects hospitalized post-procedure for infection, sepsis information based on Quick Sepsis Related Organ Failure Assessment (qSOFA) score will be collected, if available. Urinary sepsis will be defined as a qSOFA score ≥2 points	Up to 30 days post procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Ben Chew, Vancouver General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2023
• Primary Completion (Estimated): April 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Calculi; Nephrolithiasis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis; Kidney Calculi
• Other Study ID Numbers: U0701

Plan for Individual participant data (IPD)

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

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.: Yes