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

NCT07225933 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-11-10

No results posted yet for this study

Summary

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.

Conditions

  • Urolithiasis
  • Kidney Stone
  • Kidney Stones

Interventions

DEVICE

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

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

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.

Sponsors & Collaborators

  • University of California, San Diego

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • UT Southwestern Medical Center

    collaborator UNKNOWN

  • OhioHealth Research Institute

    collaborator UNKNOWN

  • Feinstein Institute for Medical Research

    collaborator OTHER

  • Summit Medical

    collaborator UNKNOWN

  • Western New York Urology Associates

    collaborator UNKNOWN

  • Calyxo, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Sur, MD · UC San Diego

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225933 on ClinicalTrials.gov