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The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Ureteroscopy (URS) | Active Comparator | This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out. |
|
| Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steerable Ureteroscopic Renal Evacuation (SURE) using the 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 |
|---|---|---|
| Residual Stone Volume (RSV) | 30-Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Standard Ureteroscopy (URS) | Device | Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out. |
|
| MidLantic Urology | Recruiting | Bala-Cynwyd | Pennsylvania | 19004 | United States |
|
| The University of Texas at Austin, Dell Medical School | Recruiting | Austin | Texas | 78712 | United States |
|
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |