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

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population.

Detailed Description
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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).

Official Title
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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)

Conditions
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Urinary Tract Disease

Intervention / Treatment
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* Device: LithoVue Ureteroscope System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LithoVue ureteroscope system<br>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. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. | Device: LithoVue Ureteroscope System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4Weeks ± 7 days from procedure |