Trials / Not Yet Recruiting
Not Yet RecruitingNCT04807010
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Society of Interventional Radiology Foundation · Academic / Other
- Sex
- Male
- Age
- 45 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Prostate Artery Embolization | Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries. |
| PROCEDURE | Sham Prostate Artery Embolization | Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization. |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2023-08-01
- Completion
- 2026-08-01
- First posted
- 2021-03-19
- Last updated
- 2021-03-19
Source: ClinicalTrials.gov record NCT04807010. Inclusion in this directory is not an endorsement.