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

Not Applicable

Completed

• Conditions: Urinary Tract Disease
• Interventions: Device: LithoVue Ureteroscope System

• Registration Number: NCT03676972
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Study Start: 2018-12-21
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-09
• Results First Submitted: 2020-12-08
• Results First Submitted QC: 2021-02-02
• Results First Posted: 2021-02-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LithoVue ureteroscope system	LithoVue Ureteroscope System	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.

Primary Outcome Measures

Name	Time	Method
Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure	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).

Trial Locations

Locations (3)

The Third Peking University Hospital; 🇨🇳 Beijing, Beijing, China

Chaoyang Hospital; 🇨🇳 Beijing, Beijng, China

The First Peking University Hospital; 🇨🇳 Beijing, Beijing, China