To Evaluate the Safety and Efficacy of… | Clinical Trial

Key information

Conditions

Urinary Tract Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Peking University Hospital, Beijing, Beijing Municipality, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Willing and able to provide written informed consent to participate in the study
Willing and able to comply with the study procedures
Diagnosed as urinary disease and indicated for flexible ureteroscope procedure
For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid staged procedures

Exclusion criteria

Surgeries are contraindicated
Flexible ureterocope procedure is contraindicated
Based on doctor's evaluation, the patient's medical condition doesn't fit for this study
For stone cases, the diameter of stones is greater than 2cm
Women of childbearing potential who are or might be pregnant at the time of this study

Treatment and study plan

LithoVue Ureteroscope System

Device

The LithoVue 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.

Primary outcomes

Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure

Time frame: 4Weeks ± 7 days from procedure

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).

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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)

Acronym: LithoVue

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Sep 19, 2018
Registry last updated: Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed