N/A N=60 Diagnostic

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

Urinary Tract Disease

Bottom Line

View on ClinicalTrials.gov: NCT03676972 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Feb 2021

Primary outcome: Primary: Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure — 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LithoVue Ureteroscope System (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure	100	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03676972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.