Urinary Tract DiseaseLithoVueNCT03676972

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

A study testing LithoVue Ureteroscope System in people with Urinary Tract Disease, run by Boston Scientific Corporation at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population. Read more about this study

Who is it for?: Any age
Conditions the study is for: Urinary Tract Disease
What is being tested?: LithoVue Ureteroscope System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesChina
Study dates: 21 Dec 2018to 9 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

China3 sites

The First Peking University Hospital
Beijing, Beijing Municipality
The Third Peking University Hospital
Beijing, Beijing Municipality
Chaoyang Hospital
Beijing, Beijng

Other trials in China

About this study

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)

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

Read the 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).

Conditions: Urinary Tract Disease
Being tested: LithoVue Ureteroscope System
Medical subject headings: Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LithoVue Ureteroscope SystemDevice
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.

Study groups in NCT03676972
Study group	Role	What they receive
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. Receives: Device: LithoVue Ureteroscope System

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 4Weeks ± 7 days from procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 20189 May 2019

First posted19 Sep 2018
Study start21 Dec 2018
Primary completion9 May 2019
Study completion9 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Urinary Tract DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03676972
Sponsor's protocol ID: U0628
Acronym: LithoVue
Status last verified: May 2021
First submitted: 30 Jul 2018
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 24147820
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.
PubMed 26344917
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.
PubMed 16813899
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.
PubMed 24837456
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.
PubMed 28287823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03676972
Acronym / sponsor ID: LithoVue / U0628
Conditions: Urinary Tract Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 21 Dec 2018 (actual)
Primary completion: 9 May 2019 (actual)
Study completion: 9 May 2019 (actual)
First posted: 19 Sep 2018 (actual)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LithoVue ureteroscope system	Experimental	Device: LithoVue Ureteroscope SystemThe 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LithoVue Ureteroscope SystemThe 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.	Device	LithoVue ureteroscope system

Primary outcome

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

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LithoVue Ureteroscope System	60	58

Primary outcome: Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure

Time frame: 4Weeks ± 7 days from procedure. Number (95% Confidence Interval). Unit: percentage of participants

Measure	LithoVue Ureteroscope System n = 60
Value	100 (95.1 to 100)

Adverse events

Time frame: Serious Adverse Events were assessed the participants in 4 weeks post procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure	5 of 60 (8.3%)	0 of 60 (0%)	1 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24147820de 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.
Background: PubMed 26344917Turk 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.
Background: PubMed 16813899Carey 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.
Background: PubMed 24837456Carey 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.
Background: PubMed 28287823Usawachintachit 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lulin Ma, Doctor principal investigator

Peking University Third Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LithoVue Ureteroscope System in people with Urinary Tract Disease, run by Boston Scientific Corporation at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure (time frame: 4Weeks ± 7 days from procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676972, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.