Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease (NCT NCT03676972)

Last Updated: 2021-11-01

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

4Weeks ± 7 days from procedure

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LithoVue Ureteroscope System n=60 Participants 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.
Age, Continuous	53.35 year STANDARD_DEVIATION 15.17 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	60 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	60 participants n=5 Participants
Body Mass Index (BMI)	25.21 kg/m^2 STANDARD_DEVIATION 4.47 • n=5 Participants
Indication for flexible ureteroscope procedures Tumor	5 Participants n=5 Participants
Indication for flexible ureteroscope procedures Stone	54 Participants n=5 Participants
Indication for flexible ureteroscope procedures ureteral stricture	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4Weeks ± 7 days from procedure

Outcome measures

Outcome measures
Measure	LithoVue Ureteroscope System n=60 Participants 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.
Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure	100 percentage of participants Interval 95.1 to 100.0

Adverse Events

All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	All-Cause Mortality and Other AE in Participants Were Assessed for up to 4 Weeks Post Procedure n=60 participants at risk 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.
Infections and infestations Urinary tract infection	1.7% 1/60 • Number of events 1 • Serious Adverse Events were assessed the participants in 4 weeks post procedure
Vascular disorders Cerebral infarction	1.7% 1/60 • Number of events 1 • Serious Adverse Events were assessed the participants in 4 weeks post procedure
Respiratory, thoracic and mediastinal disorders Dyspnea	1.7% 1/60 • Number of events 1 • Serious Adverse Events were assessed the participants in 4 weeks post procedure
Blood and lymphatic system disorders Fever	1.7% 1/60 • Number of events 1 • Serious Adverse Events were assessed the participants in 4 weeks post procedure
Surgical and medical procedures Fistula rupture	1.7% 1/60 • Number of events 1 • Serious Adverse Events were assessed the participants in 4 weeks post procedure

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lulin Ma

Peking University Third Hospital

Phone: 13701010872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place