Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorCalyxo, Inc.
Industry-sponsored
Locations6 sites (Birmingham, Alabama and 5 other locations)
StatusRecruiting
StartedMay 21, 2026
Main results expectedJuly 2027
Study endsJuly 2029
Registry record updatedOctober 28, 2026
Trial IDNCT07101809 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.