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

Boston Scientific Corporation60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Urinary Tract Disease

Interventions

LithoVue Ureteroscope SystemDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willing and able to provide written informed consent to participate in the study 2. Willing and able to comply with the study procedures 3. Diagnosed as urinary disease and indicated for flexible ureteroscope procedure 4. For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid staged procedures Exclusion Criteria: 1. Surgeries are contraindicated 2. Flexible ureterocope procedure is contraindicated 3. Based on doctor's evaluation, the patient's medical condition doesn't fit for this study 4. For stone cases, the diameter of stones is greater than 2cm 5. Women of childbearing potential who are or might be pregnant at the time of this study

Locations (3)

The First Peking University Hospital

Beijing, Beijing Municipality, China

The Third Peking University Hospital

Beijing, Beijing Municipality, China

Chaoyang Hospital

Beijing, Beijng, China

Outcomes

Primary Outcomes

Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 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).

Time frame: 4Weeks ± 7 days from procedure

Data from ClinicalTrials.gov

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