To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease — LithoVue

Urinary Tract Disease Clinical Trial

Official title:
A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease(LithoVue China Study)

Status Completed

Clinical Trial Summary

To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population.

Clinical Trial Description

This is a prospective, multicenter, single-arm, pre-market study.The aim of this study is to evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population, to support the regulatory approval by CFDA. The study will enroll 60 patients in 3 investigational sites in China. The primary endpoint is procedure success rate of LithoVue ureteroscope system, the procedure success is defined as:Scope condition is suitable to complete the procedure and not requiring immediate scope substitution; it is also considered as a procedure success if the clinical effect is the same as that from the LithoVue scope per investigator's judgement in the case of a scope change (non-LithoVue). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03676972
Study type	Interventional
Source	Boston Scientific Corporation
Contact
Status	Completed
Phase	N/A
Start date	December 21, 2018
Completion date	May 9, 2019

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