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Comparison of Glue with Microparticles in Prostatic Artery Embolization

NCT06678308 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-11-07

No results posted yet for this study

Summary

Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy.

The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.

The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size.

Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety.

In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Embolisation with Magic Glue®

Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland

DEVICE

Embolisation with Embosphere®

Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland

Sponsors & Collaborators

  • Almaviva Sante

    lead OTHER

Principal Investigators

  • Grégory AMOUYAL, MD · Clinique de l'Alma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • France

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 NCT06678308 on ClinicalTrials.gov