Recruiting

SURE vs. URS

Sponsor:

Calyxo, Inc.

Code:

NCT07101809

Conditions

Urolithiasis

Stones, Kidney

Renal Stones

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

Standard Ureteroscopy (URS)

Study Details

Brief 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.

Conditions

Urolithiasis

Stones, Kidney

Renal Stones

Kidney Stones

Study ID

NCT07101809

Start date

May 21, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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).

Interventions

Steerable 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).

Standard 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.

Primary outcome measure

  • Residual Stone Volume (RSV) [ Time Frame: 30-Day ]

Central Contacts and Locations

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Samuel P. Dransfield, MS

205-641-6620sdransfield@uabmc.edu

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

John Marks

352-273-5618marksjg@ufl.edu

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Monali Fatterpekar, PhD

212-241-0751monali.fatterpekar@mountsinai.org

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Contacts

Cheryl Zinar, RN, BSN

610-667-0458czinar@midlanticurology.com

The University of Texas at Austin, Dell Medical School

Recruiting

Austin, Texas, United States, 78712

Contacts

Swetha Venkataraman

512-495-2201swetha.venkataraman@austin.utexas.edu

More Information

Sponsor

Calyxo, Inc.

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • ureteroscopy
  • CVAC
  • SURE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Calyxo, Inc. on 2026-07-23.