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The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Subjects who still have stone present at Day 30 will be evaluated again at Day 60. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The ELS Trial is a prospective, multi-center, single arm study. | Experimental | All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELS (Enhanced Lithotripsy System) | Device | ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (<=4 mm) at 30 Days post procedure. | From ELS treatment to 30 Days afterward. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis Marcoux | Contact | 415-887-2037 | louis.marcoux@avviomed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State Urological Research Institute | Recruiting | Phoenix | Arizona | 85225 | United States |
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| Arkansas Urology Research Center | Enrolling by invitation | Little Rock | Arkansas | 72211 | United States |
| Michael G. Oefelein Clinical Trials | Active, not recruiting | Bakersfield | California | 93301 | United States |
| San Diego Clinical Trials | Recruiting | La Mesa | California | 91942 | United States |
|
| Golden State Urology | Recruiting | Sacramento | California | 95823 | United States |
|
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
|
| Georgia Urology | Recruiting | Roswell | Georgia | 300076 | United States |
|
| Comprehensive Urologic Care | Recruiting | Lake Barrington | Illinois | 60010 | United States |
|
| Wichita Urology Group | Recruiting | Wichita | Kansas | 67226 | United States |
|
| Minnesota Urology | Recruiting | Woodbury | Minnesota | 55125 | United States |
|
| Nebraska Urology | Enrolling by invitation | Lincoln | Nebraska | 68516 | United States |
| Urology Nevada | Enrolling by invitation | Reno | Nevada | 89511 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14620 | United States |
|
| SUNY - Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
|
| Duke | Active, not recruiting | Durham | North Carolina | 27710 | United States |
| Urology Specialists Clinic | Enrolling by invitation | Sioux City | South Dakota | 57108 | United States |
| Urology San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Virginia | Withdrawn | Charlottesville | Virginia | 22903 | United States |
| University of Virginia Community Health | Active, not recruiting | Culpeper | Virginia | 22701 | United States |
| Urology of Virginia | Recruiting | Virginia Beach | Virginia | 23462 | United States |
|
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
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