LithoVue Elite Registry

Urolithiasis Clinical Trial

— LVE  

Official title:

LithoVue Elite (LVE) Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05201456
• Other study ID #: U0701
• Status: Withdrawn
• Start date: April 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Urolithiasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Post-operative Infection - Additional Endpoint	Post-operative infection within 30 days of the procedure	Up to 30 days post procedure
Other	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
Other	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
Primary	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
Primary	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	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