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NCT Number: NCT07225933

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System

This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stone Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego (UCSD)

La Jolla, California, 92093-0934, United States

About this study

The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects that had SURE procedure with CVAC System performed in the retrospective cohort
  • Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort

Exclusion criteria

  • For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones

Treatment and study plan

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).

Other names: SURE, CVAC

FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)

Device

FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.

Other names: FANS, fURS

Primary outcomes

  1. Stone free Status

    Time frame: Post-Operative up to 90 Days

    Completed by reviewing any available standard of care post-procedure imaging

  2. Intra- & Post-Operative Complications

    Time frame: Intra- & Post-Operative up to 90 Days

    Completed by reviewing data available for intra- and post-op complications

Sponsors and collaborators

Lead sponsor

Calyxo, Inc.

Industry

Collaborators

  • Feinstein Institute for Medical Research
  • OhioHealth Research Institute
  • Summit Medical
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Texas Southwestern Medical Center
  • Western New York Urology Associates

Registry information

Acronym: REASON

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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