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Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

NCT03109925 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-10-22

No results posted yet for this study

Summary

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

DC Lumi Bead, BTG

Embolic agent which is radio-opaque

Sponsors & Collaborators

  • BTG International Inc.

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Timothy Bryant · University of Hospital Southampton

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109925 on ClinicalTrials.gov