LithoVue Elite Registry (LVE)

Boston Scientific

Status: Withdrawn

Conditions: Urolithiasis; Kidney Stone

Treatments: Device: LithoVue Elite System

Study type: Observational

Funder types: Industry

Identifiers

NCT05201456

U0701

Details and patient eligibility

About

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Pressure Monitoring

Description:

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.

Treatment:

Device: LithoVue Elite System

Non-Pressure Monitoring

Description:

Subjects in this cohort will undergo ureteroscopic procedure using LithoVue Elite Non-pressure monitoring single use flexible scope.

Treatment:

Device: LithoVue Elite System