Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

N/ANot Yet RecruitingNCT07101809

Calyxo, Inc.150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Urolithiasis Stones, Kidney Renal Stones Kidney Stones

Interventions

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Residual Stone Volume (RSV)

Time frame: 30-Day

Data from ClinicalTrials.gov

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