LithoVue Elite Registry

NCT05201456 | Withdrawn FDA Device

• 1 other identifier: U0701
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Kidney Stone; Urolithiasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint

  Up to 120 days of follow up

Other Outcomes (6)

• Stone Free Rate - Additional Endpoint

  Up to 120 days of follow up

• Surgeon Satisfaction with use of Scope - Additional Endpoint

  Procedure

• Post-operative Pain (Brief Pain Inventory (BPI)) - Additional Endpoint

  Discharge, 7 days post procedure and 30 days post procedure

Study Arms (2)

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

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

Interventions

LithoVue Elite System 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.

Non-Pressure Monitoring; Pressure Monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Chew

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 21, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share