An interventional study of LithoVue Ureteroscope System in Urinary Tract Disease, sponsored by Boston Scientific Corporation. Completed at 3 sites in China. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Diagnostic
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).
193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 135 interventional studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Exclusion Criteria:
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
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.
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).
Time frame: 4Weeks ± 7 days from procedure
| Milestone | LithoVue Ureteroscope System |
|---|---|
| Started | 60 |
| Completed | 58 |
| Not completed | 2 |
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).
| percentage of participants | LithoVue Ureteroscope System |
|---|---|
| Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure | 100 (95.1 to 100) |
Collected over Serious Adverse Events were assessed the participants in 4 weeks post procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure | 1/60 (1.7%) | 5/60 (8.3%) | 0/60 (0%) |
| Event | All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure |
|---|---|
| Urinary tract infectionInfections and infestations | 1/60 |
| Cerebral infarctionVascular disorders | 1/60 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/60 |
| FeverBlood and lymphatic system disorders | 1/60 |
| Fistula ruptureSurgical and medical procedures | 1/60 |
Of the 60 subjects, 54 patients had stones, 5 patients had tumors, and 1 patient had ureteral stricture.
| Age, Continuous(year) | LithoVue Ureteroscope System |
|---|---|
| Geometric mean | 53.35 ± 15.17 |
| Sex: Female, Male(Participants) | LithoVue Ureteroscope System |
|---|---|
| Female | 26 |
| Male | 34 |
| Race (NIH/OMB)(Participants) | LithoVue Ureteroscope System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 60 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | LithoVue Ureteroscope System |
|---|---|
| China | 60 |
| Body Mass Index (BMI)(kg/m^2) | LithoVue Ureteroscope System |
|---|---|
| Geometric mean | 25.21 ± 4.47 |
| Indication for flexible ureteroscope procedures(Participants) | LithoVue Ureteroscope System |
|---|---|
| Tumor | 5 |
| Stone | 54 |
| ureteral stricture | 1 |
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