CClinicalTrials.gg
RecruitingNCT07101809TRUSTUpdated Jul 23, 2026

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

An interventional study of Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and Standard Ureteroscopy (URS) in Urolithiasis, Stones, Kidney and Renal Stones, sponsored by Calyxo, Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Calyxo, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

02

Conditions studied

  • Urolithiasis
  • Stones, Kidney
  • Renal Stones
  • Kidney Stones

Keywords

  • ureteroscopy
  • CVAC
  • SURE
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Standard Ureteroscopy (URS)

    This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.

    Device: Standard Ureteroscopy (URS)

  • Active comparator
    Steerable Ureteroscopic Renal Evacuation (SURE) with 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).

    Device: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

Interventions

  • DeviceSteerable Ureteroscopic Renal Evacuation (SURE) using 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).

    Also known as: CVAC

  • DeviceStandard Ureteroscopy (URS)

    Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.

05

What researchers measure

Primary outcomes

  1. Residual Stone Volume (RSV)

    Time frame: 30-Day

06

Study locations

5 of 5 sites recruiting
  • The University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
  • University of Florida
    Gainesville, Florida 32611, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
  • MidLantic Urology
    Bala-Cynwyd, Pennsylvania 19004, United States
    Recruiting
  • The University of Texas at Austin, Dell Medical School
    Austin, Texas 78712, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07101809
Lead sponsor
Calyxo, Inc.
Responsible party
Sponsor
First posted
Aug 3, 2025
Start date
May 21, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2029 (estimated)
Last update
Jul 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion