A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 132
- Locations
- 11
- Primary Endpoint
- Stone Free Rate (SFR) - Zero Fragments
Study Overview
Brief Summary
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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;
- •Presence of renal stone(s);
- •Be willing and able to return for all study-related follow up procedures; and,
- •Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.
Exclusion Criteria
- •BMI > 45;
- •Significant comorbidities;
- •Bladder, ureteral or kidney abnormalities;
- •Pregnant individuals; or
- •Unable to meet the treatment and follow up protocol requirements.
Arms & Interventions
SURE
Intervention: SURE (Device)
Standard Ureteroscopy (Basketing)
Intervention: Standard Ureteroscopy (Basketing) (Device)
Outcomes
Primary Outcomes
Stone Free Rate (SFR) - Zero Fragments
Time Frame: 30 Days
The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm.
Secondary Outcomes
- Residual Stone Volume (RSV)(30 Days)
- Stone Clearance (% Reduction in Stone Volume)(30 Days)