ClinicalTrials.gg
RecruitingNCT07101809TRUSTUpdated Oct 28, 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 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Primary conditionKidney CalculiRegistry: UrolithiasisReclassifiedWhy we changed it
Registry
Urolithiasis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Calculi
Why
  1. The study's listed conditions name Kidney Calculi, a narrower term within Urolithiasis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 28, 20261 site addedGo to Updates ↓
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

Browse trials for

Keywords

  • ureteroscopy
  • CVAC
  • SURE
03

In context

Kidney Calculi Reclassified

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 150 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

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 Urolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

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.

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 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
Terms in these criteria, in plain language(1)

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.

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.

05

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.

06

What researchers measure

Primary outcomes

  1. Residual Stone Volume (RSV)

    Time frame: 30-Day

07

Study locations

6 of 6 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jul 2027, 14 months after the start.

Of 199 interventional studies with no phase under Kidney Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2025
First posted
Aug 3, 2025
StartActual
May 21, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2029
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • OhioHealth Research Institute · Columbus, United States
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    1 site added
    Show site
    • OhioHealth Research Institute · Columbus, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

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
Oct 28, 2026

Oversight

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

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