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

November 6, 2025 updated by: Calyxo, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0934
        • University of California San Diego (UCSD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects that are 18 or older that underwent the SURE procedure with the CVAC System or fURS with FANS in the retrospective cohort

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • FANS
  • fURS
Steerable Ureteroscopic Renal Evacuation (SURE) with 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: 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).
Other Names:
  • CVAC
  • SURE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free Status
Time Frame: Post-Operative up to 90 Days
Completed by reviewing any available standard of care post-procedure imaging
Post-Operative up to 90 Days
Intra- & Post-Operative Complications
Time Frame: Intra- & Post-Operative up to 90 Days
Completed by reviewing data available for intra- and post-op complications
Intra- & Post-Operative up to 90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calyxo, Inc.

Collaborators

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

Investigators

  • Principal Investigator: Roger Sur, MD, UC San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 5, 2025

First Submitted That Met QC Criteria

November 6, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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