N/A
N=30
CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones
Renal Stones · Kidney Stone · Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT06615713 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Stone Clearance (% Reduction in Stone Volume) — 96.2 % stone volume removed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Calyxo, Inc.
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Clearance (% Reduction in Stone Volume) |
96.2 | — |
| PRIMARY Residual Stone Volume (RSV) |
14.1 | — |
| PRIMARY Stone Free Rate (SFR) - Zero Fragments |
13 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06615713). 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.