Urinary Tract Disease
Conditions
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).
Interventions
DEVICELithoVue 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure | 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). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | LithoVue Ureteroscope System |
|---|---|
| Age, Continuous | 53.35 year STANDARD_DEVIATION 15.17 |
| Body Mass Index (BMI) | 25.21 kg/m^2 STANDARD_DEVIATION 4.47 |
| Indication for flexible ureteroscope procedures Stone | 54 Participants |
| Indication for flexible ureteroscope procedures Tumor | 5 Participants |
| Indication for flexible ureteroscope procedures ureteral stricture | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 60 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 5 / 60 |
Outcome results
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).
Time frame: 4Weeks ± 7 days from procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LithoVue Ureteroscope System | Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure | 100 percentage of participants |