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
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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ACTIVE_NOT_RECRUITING
3000 participants
OBSERVATIONAL
2024-02-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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)
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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
University of Alabama at Birmingham
OTHER
UT Southwestern Medical Center
UNKNOWN
OhioHealth Research Institute
UNKNOWN
Feinstein Institute for Medical Research
OTHER
Summit Medical
UNKNOWN
Western New York Urology Associates
UNKNOWN
Calyxo, Inc.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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CP00005
Identifier Type: -
Identifier Source: org_study_id
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