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

Urinary Tract Disease Clinical Trial

— LithoVue  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676972
• Other study ID #: U0628
• Status: Completed
• Phase: N/A
• Start date: December 21, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: May 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Disease
• Urologic Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Chaoyang Hospital	Beijing	Beijng
China	The First Peking University Hospital	Beijing	Beijing
China	The Third Peking University Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

References & Publications (5)

Carey RI, Gomez CS, Maurici G, Lynne CM, Leveillee RJ, Bird VG. Frequency of ureteroscope damage seen at a tertiary care center. J Urol. 2006 Aug;176(2):607-10; discussion 610. — View Citation

Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14. — View Citation

de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17. — View Citation

Türk C, Petrík A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Interventional Treatment for Urolithiasis. Eur Urol. 2016 Mar;69(3):475-82. doi: 10.1016/j.eururo.2015.07.041. Epub 2015 Sep 4. Review. — View Citation

Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T. A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. J Endourol. 2017 May;31(5):468-475. doi: 10.1089/end.2017.0027. Epub 2017 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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