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

Primary Purpose

Urinary Tract Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LithoVue Ureteroscope System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Peking University Hospital
  • The Third Peking University Hospital
  • Chaoyang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LithoVue ureteroscope system

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 30, 2018
Last Updated
October 20, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03676972
Brief Title
To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LithoVue ureteroscope system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
LithoVue Ureteroscope System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure
Description
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).
Time Frame
4Weeks ± 7 days from procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lulin Ma, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Peking University Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Third Peking University Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chaoyang Hospital
City
Beijing
State/Province
Beijng
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24147820
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.
Results Reference
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PubMed Identifier
26344917
Citation
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.
Results Reference
background
PubMed Identifier
16813899
Citation
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.
Results Reference
background
PubMed Identifier
24837456
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.
Results Reference
background
PubMed Identifier
28287823
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.
Results Reference
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To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease

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