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

NCT ID: NCT07225933

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urolithiasis Kidney Stone Kidney Stones

Keywords

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SURE FANS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

CVAC® SYSTEM

Intervention Type 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).

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.

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

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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SURE CVAC FANS fURS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

UT Southwestern Medical Center

UNKNOWN

Sponsor Role collaborator

OhioHealth Research Institute

UNKNOWN

Sponsor Role collaborator

Feinstein Institute for Medical Research

OTHER

Sponsor Role collaborator

Summit Medical

UNKNOWN

Sponsor Role collaborator

Western New York Urology Associates

UNKNOWN

Sponsor Role collaborator

Calyxo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Sur, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

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University of California San Diego (UCSD)

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP00005

Identifier Type: -

Identifier Source: org_study_id