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NCT03372096 · ClinicalTrials.gov registry record · NA
LC Bead LUMI for Prostatic Artery Embolization
A NA study of BPH, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT03372096 is a NA study of BPH that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants, below the 67-participant average among 5 other BPH trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03372096, a NA study of BPH, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Conditions Studied
Interventions
- DEVICE Prostatic Artery Embolization
Study Locations (2)
North Carolina
- UNC Hospitals - Chapel Hill
Virginia
- Vascular Institute of Virginia - Woodbridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2020-09-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03372096
The ClinicalTrials.gov registry entry for NCT03372096 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 5 other BPH trials with a reported enrollment target (73% lower). 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 1 condition, with BPH appearing as the primary indexed condition, and to 1 intervention - of which Prostatic Artery Embolization is the first listed.
NCT03372096 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT03372096 about?
NCT03372096 is a clinical study titled "LC Bead LUMI for Prostatic Artery Embolization". Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residu...
What is the current status of trial NCT03372096?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2018-07-13. Estimated completion is 2020-09-03.
What conditions does trial NCT03372096 study?
This clinical trial studies the following conditions: BPH.
What interventions are being tested in trial NCT03372096?
The interventions under investigation include: Prostatic Artery Embolization (DEVICE).
Who is sponsoring clinical trial NCT03372096?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03372096 being conducted?
This trial has 2 study locations across North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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