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NCT04398966 · ClinicalTrials.gov registry record · NA
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04398966: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.
NCT04398966 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04398966, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites. Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
Primary Outcome
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Interventions
- DEVICE Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2023-05-08 |
| Phase | NA |
Why NCT04398966 stopped before completion
NCT04398966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Prostatic Artery Embolization (HydroPearl® compressible microspheres) is the first listed.
NCT04398966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04398966 about?
NCT04398966 is a clinical study titled "Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia". Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in indivi...
What is the current status of trial NCT04398966?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2020-09-23. Estimated completion is 2023-05-08.
What interventions are being tested in trial NCT04398966?
The interventions under investigation include: Prostatic Artery Embolization (HydroPearl® compressible microspheres) (DEVICE).
Who is sponsoring clinical trial NCT04398966?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04398966's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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