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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 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04398966
The ClinicalTrials.gov registry entry for NCT04398966 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prostatic Artery Embolization (HydroPearl® compressible microspheres) is the first listed.
NCT04398966 reports 0 study locations.
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.
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