Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Calyxo, Inc.
Study ID
NCT07101809
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System — DEVICE
    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) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35294
Samuel P. Dransfield, MS
[email protected]
205-641-6620
MidLantic UrologyBala-CynwydPennsylvania19004
Cheryl Zinar, RN, BSN
[email protected]
610-667-0458
The University of Texas at Austin, Dell Medical SchoolAustinTexas78712
Swetha Venkataraman
[email protected]
512-495-2201

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALMidLantic Urology· Bala-Cynwyd, PAThe University of Texas at Austin, Dell Medical School· Austin, TX

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