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

NCT ID: NCT03676972

Last Updated: 2021-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2019-05-09

Brief Summary

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

Detailed Description

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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).

Conditions

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Urinary Tract Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LithoVue Ureteroscope System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lulin Ma, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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The First Peking University Hospital

Beijing, Beijing Municipality, China

Site Status

The Third Peking University Hospital

Beijing, Beijing Municipality, China

Site Status

Chaoyang Hospital

Beijing, Beijng, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24147820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26344917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16813899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24837456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28287823 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U0628

Identifier Type: -

Identifier Source: org_study_id