Menu
Recruiting NCT07101809

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

No phase Interventional Urolithiasis Stones, Kidney Renal Stones Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System, Standard Ureteroscopy (URS).
Who it may be relevant to
Registry conditions: Urolithiasis, Stones, Kidney, Renal Stones, Kidney Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial

Overview

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.

Interventions

  • 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).
  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • The University of Alabama at Birmingham — Birmingham
  • University of Florida — Gainesville
  • Icahn School of Medicine at Mount Sinai — New York
  • MidLantic Urology — Bala-Cynwyd
  • The University of Texas at Austin, Dell Medical School — Austin

Identifiers

NCT: NCT07101809 · CP00006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗