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| ID | Type | Description | Link |
|---|---|---|---|
| CP00022 | Other Identifier | NeoTract |
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Sponsor decided to cancel the study due to the study design
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The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UroLift System | Therapy to be treatment with the UroLift System. |
| |
| Watchful Waiting or BPH Medications | Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. |
| |
| Other Surgical Intervention | Physician decides the best course of therapy to be a surgical intervention other than the UroLift System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroLift System | Device | The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra. |
| Measure | Description | Time Frame |
|---|---|---|
| To identify responders of IPSS change | Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit. | 3 months post-treatment visit |
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Inclusion Criteria:
Exclusion Criteria:
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Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neotract Inc | Pleasanton | California | 94566 | United States |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Watchful Waiting or BPH Medications | Other | Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. |
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| Other Surgical Intervention | Device | Physician decides the best course of therapy to be a surgical intervention other than the UroLift System. |
|
| D052801 |
| Male Urogenital Diseases |