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NCT03527589 · ClinicalTrials.gov registry record
Embosphere® PROstate Post Market Study
A clinical trial, sponsored by Merit Medical Systems.
- Completed
- Registry status
- 499
- Enrollment target
NCT03527589: Completed study, sponsored by Merit Medical Systems.
NCT03527589 is a clinical trial that has completed, run by Merit Medical Systems. The registered enrollment target is 499 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03527589 has completed, sponsored by Merit Medical Systems.
- COMPLETED
- Registry status
- 499 participants
- Enrollment target
Study Summary
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.
Primary Outcome
The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and th
Interventions
- DEVICE Prostate artery embolization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2018-08-16 |
| Est. Completion | 2022-01-22 |
What the finished NCT03527589 record still lists
NCT03527589 is an observational study that tracks outcomes without assigning an intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Prostate artery embolization is the first listed.
NCT03527589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03527589 about?
NCT03527589 is a clinical study titled "Embosphere® PROstate Post Market Study". Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.
What is the current status of trial NCT03527589?
This trial is currently completed. The enrollment target is 499 participants. The study started on 2018-08-16. Estimated completion is 2022-01-22.
What interventions are being tested in trial NCT03527589?
The interventions under investigation include: Prostate artery embolization (DEVICE).
Who is sponsoring clinical trial NCT03527589?
This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.
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