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

NCT07225933 | Active Not Recruiting FDA Device

• 1 other identifier: CP00005
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SURE; FANS

Outcome Measures

Primary Outcomes (2)

• Stone free Status

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

  Post-Operative up to 90 Days

• Intra- & Post-Operative Complications

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

  Intra- & Post-Operative up to 90 Days

Study Arms (2)

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

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)

Interventions

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).

Also known as: SURE, CVAC

Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System

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.

Also known as: FANS, fURS

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of California San Diego (UCSD)

La Jolla, California, 92093-0934, United States

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Roger Sur, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: February 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)