Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC vs standard ureteroscopy
Official title: Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
Run by Calyxo, Inc. · NCT07101809 · Data updated 2026-11-12
This trial tests whether the SURE system with CVAC can improve outcomes compared with standard ureteroscopy with laser lithotripsy for kidney stones in adult patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Calyxo, Inc. Industry-sponsored |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Status | Recruiting |
| Started | May 21, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07101809 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing ureteroscopy with laser lithotripsy for kidney stones who can commit to follow-up and provide informed consent.
✕Probably not a fit
Patients with active untreated urinary tract infection, significant comorbidities, or anatomical abnormalities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study compares two ureteroscopy approaches for treating kidney stones: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC system versus conventional ureteroscopy with laser lithotripsy. Participants are assigned 1:1 across multiple centers and will undergo follow-up procedures per the protocol. The study aims to evaluate safety and effectiveness of the two techniques in a real-world clinical setting. Enrollment requires candidates for ureteroscopy with laser lithotripsy who can comply with follow-up and provide informed consent.
Why it matters
Potential benefit: If successful, patients could benefit from a potentially more efficient stone removal method and improved recovery.
How similar studies have gone: Prior trials in similar endoscopic techniques have shown promise, but this direct comparison to SURE with CVAC is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 * Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF) Exclusion Criteria: * Untreated urinary tract infection at the time of the index procedure * Significant comorbidities * Bladder, ureteral or kidney abnormalities * Pregnant individuals * Unable to meet the treatment and follow up protocol requirements
Where it's running
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The University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
University of Florida
Gainesville, Florida, United States Recruiting -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting -
OhioHealth Research Institute
Columbus, Ohio, United States Recruiting -
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States Recruiting -
The University of Texas at Austin, Dell Medical School
Austin, Texas, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Stone clearance with steerable ureteroscopic evacuation compared with other methods
This study tests whether the CVAC/SURE approach helps clear kidney stones more effectively than standard renal-stone interventions in patients needing ureteroscopy or PCNL.
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This study is testing whether a robotic system works better than traditional manual methods for treating kidney stones to see which approach is safer and more effective for adults.
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This study is testing if people with calcium oxalate kidney stones produce more oxalate in their bodies than healthy individuals by following a special diet and taking certain supplements.
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Acupressure to Ease Pain During ESWL for Kidney Stones
This study tests whether applying acupressure to specific points before ESWL can reduce pain and improve comfort for adults with kidney or proximal ureteral stones.
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Audio consent with human voice or AI-voice added to written consent for ureteroscopy
This study tests if listening to an audio version of the consent form, read by a real urologist or by an AI-cloned voice, helps adults in Turkey understand their ureteroscopy or RIRS consent better than the written form alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.