BPH Clinical Trial - LC Bead LUMI for Prostatic Artery Embolization

Status Completed

Clinical Trial 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.

Clinical Trial Description

This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03372096
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	July 13, 2018
Completion date	September 3, 2020

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