Kidney Stone, Kidney Stones, Urolithiasis
Conditions
Keywords
SURE, FANS
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.
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.
Interventions
DEVICECVAC® 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).
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
University of California, San Diego
University of Alabama at Birmingham
University of Texas Southwestern Medical Center
OhioHealth Research Institute
Feinstein Institute for Medical Research
Summit Medical
Western New York Urology Associates
Calyxo, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free Status | Post-Operative up to 90 Days | Completed by reviewing any available standard of care post-procedure imaging |
| Intra- & Post-Operative Complications | Intra- & Post-Operative up to 90 Days | Completed by reviewing data available for intra- and post-op complications |
Countries
United States
Outcome results
None listed