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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects that are 18 or older that underwent the SURE procedure with the CVAC System or fURS with FANS in the retrospective cohort
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| Name | Affiliation | Role |
|---|---|---|
| Roger Sur, MD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego (UCSD) | La Jolla | California | 92093-0934 | United States |
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| OhioHealth Research Institute |
| UNKNOWN |
| Feinstein Institute for Medical Research | OTHER |
| Summit Medical | UNKNOWN |
| Western New York Urology Associates | UNKNOWN |
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| 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. |
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|
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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