An interventional study of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System in Renal Stones, Kidney Stone and Urolithiasis, sponsored by Calyxo, Inc.. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Calyxo, Inc. · Not applicable, Interventional, and Treatment
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 30 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Calyxo, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nephrolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: 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).
Stone Clearance (% Reduction in Stone Volume)
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.
Time frame: 30 Days
Residual Stone Volume (RSV)
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
Time frame: 30 Days
Stone Free Rate (SFR) - Zero Fragments
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.
Time frame: 30 Days
| Milestone | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Started | 30 |
| Completed | 26 |
| Not completed | 4 |
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.
| % stone volume removed | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Stone Clearance (% Reduction in Stone Volume) | 96.2 ± 6.5 |
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
| mm^3 | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Residual Stone Volume (RSV) | 14.1 ± 23.0 |
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.
| kidneys | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Stone Free Rate (SFR) - Zero Fragments | 13 |
Collected over Index Procedure to Post-op Day-30 (POD30). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) |
| Event | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Urinary Tract Infection (UTI)Renal and urinary disorders | 2/30 |
| Age, Continuous(years) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Mean | 48 ± 16.2 |
| Sex: Female, Male(Participants) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Female | 10 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|
| Region of Enrollment(participants) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| India | 30 |
| Stone Density(HU) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Mean | 1203 ± 345 |
| Total Stone Volume(mm^3) | Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System |
|---|---|
| Mean | 703.6 ± 835.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Calyxo, Inc.