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

  • End date
    Jul 21, 2024
  • participants needed
  • sponsor
    Calyxo, Inc.
Updated on 21 October 2022


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.

Condition Kidney Stone, Renal Stone, Urolithiasis
Treatment SURE, SURE, Standard Ureteroscopy (Basketing)
Clinical Study IdentifierNCT04519294
SponsorCalyxo, Inc.
Last Modified on21 October 2022


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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