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The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenflow Spring System | Device | Minimally Invasive Treatment for LUTS associated with BPH |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness - IPSS | The primary effectiveness endpoint is the change in IPSS from baseline over time | Baseline to 12 Months |
| Safety - adverse events | The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs) | Baseline to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Clinical Trials | La Mesa | California | 91942 | United States | ||
| Midtown Urology Associates |
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| Austin |
| Texas |
| 78705 |
| United States |
|
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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