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To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lulin Ma, Doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Peking University Hospital | Beijing | Beijing Municipality | China | |||
| The Third Peking University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24147820 | Background | 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. | |
| 26344917 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of the 60 subjects, 54 patients had stones, 5 patients had tumors, and 1 patient had ureteral stricture.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 4Weeks ± 7 days from procedure |
|
Serious Adverse Events were assessed the participants in 4 weeks post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment | urinary tract infection at four weeks after surgery, which improved after in-patient treatment, then the patient was discharged from the hospital. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lulin Ma | Peking University Third Hospital | 13701010872 | +86 | malulin@medmail.com.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2018 | Dec 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2019 | Dec 1, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Beijing |
| Beijing Municipality |
| China |
| Chaoyang Hospital | Beijing | Beijng | China |
| 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. |
| 16813899 | 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. |
| 24837456 | 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. |
| 28287823 | 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. |
| Standard Deviation |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Height (cm) and Weight (kg), The formula for BMI is weight in kilograms divided by height in meters squared | Geometric Mean | Standard Deviation | kg/m^2 |
|
| Indication for flexible ureteroscope procedures | Count of Participants | Participants |
|
|
|
| 1 |
| 60 |
| 5 |
| 60 |
| 0 |
| 60 |
|
| Cerebral infarction | Vascular disorders | MedDRA 10.0 | Systematic Assessment | This SAE case was the death of a patient, who died due to acute cerebral infarction 18 days after surgery. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | The SAE was sudden dyspnea of a patient during the resuscitation from anesthesia process after the procedure concluded. |
|
| Fever | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | The SAE was fever, which improved after symptomatic treatment |
|
| Fistula rupture | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment | The SAE was the rupture of the fistula that needed to be indwelled for the discharge of stones after the stone surgery during extubation, and the patient improved after hospitalization during which the remaining fistula in the body was pulled out. |
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