Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

NCT07101809 · tracked via the Priya Life Science USA tracker

Sponsor

Calyxo, Inc.

Phase

Not applicable

Started

2026-05-21

Last updated

2026-07-23

Condition(s) studied

UrolithiasisStones, KidneyRenal StonesKidney Stones

Investigational drug(s) / intervention(s)

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemStandard Ureteroscopy (URS)

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Residual Stone Volume (RSV) — 30-Day

Trial sites (5)

Facility	City	Region	Status
The University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
MidLantic Urology	Bala-Cynwyd	Pennsylvania	Recruiting
The University of Texas at Austin, Dell Medical School	Austin	Texas	Recruiting

More Calyxo, Inc. trials in the USA

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System Active, not recruiting

Other trials for the same condition

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07101809 on ClinicalTrials.gov ↗ ← All trials in the USA