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

NCT03676972 | Completed Results FDA Device

• 1 other identifier: U0628
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Urinary Tract Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LithoVue ureteroscope system

EXPERIMENTAL

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

Interventions

LithoVue Ureteroscope System DEVICE

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.

LithoVue ureteroscope system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

The First Peking University Hospital

Beijing, Beijing Municipality, China

Location

The Third Peking University Hospital

Beijing, Beijing Municipality, China

Location

Chaoyang Hospital

Beijing, Beijng, China

Location

Related Publications (5)

• 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.

  PMID: 24147820 BACKGROUND

• Turk C, Petrik 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.

  PMID: 26344917 BACKGROUND

• 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. doi: 10.1016/j.juro.2006.03.059.

  PMID: 16813899 BACKGROUND

• 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.

  PMID: 24837456 BACKGROUND

• 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.

  PMID: 28287823 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Lulin Ma
• Organization: Peking University Third Hospital

malulin@medmail.com.cn

13701010872

Study Officials

• Lulin Ma, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: September 19, 2018
• Study Start: December 21, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: November 1, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)