Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

  • 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)
    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.
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
    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).
    Other names:
    • CVAC

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Samuel P. Dransfield, MS
205-641-6620
sdransfield@uabmc.edu

More Details

Status
Recruiting
Sponsor
Calyxo, Inc.

Study Contact