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