A Prospective Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® Set
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Stone Clearance
Study Overview
Brief Summary
The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Candidate for ureteroscopy with laser lithotripsy;
- •Be willing and able to return for and respond to all study-related follow up procedures; and,
- •Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).
Exclusion Criteria
- •Significant morbidities;
- •Unable to meet the treatment and follow up protocol requirements; and,
- •Ureteral or kidney abnormalities.
Arms & Interventions
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Intervention: Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System (Device)
Outcomes
Primary Outcomes
Stone Clearance
Time Frame: Day 1 and Day 30
The stone clearance at Post-Op Day 1 (POD1) and Post-Op Day 30 (POD30) on non-contrast CT (NCCT)
Stone Clearance (% Reduction in Stone Volume)
Time Frame: 30 Days
The percent reduction (\[Baseline stone volume- 30-Day stone volume\] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure.
Residual Stone Volume (RSV)
Time Frame: 30 Days
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
Stone Free Rate (SFR) - Zero Fragments
Time Frame: 30 Days
Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm.
Secondary Outcomes
No secondary outcomes reported