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NOT YET RECRUITING
NCT07255508

Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results. The aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-11

Completion Date

2027-11

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DEVICE

Liquid embolic agent

Prostatic Artery Embolization using a non-adhesive liquid embolic agent composed of an EVOH (ethylene-vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), with micronized tantalum powder suspended within it

Locations (4)

Hôpital Timone (Radiologie adultes et neuroradiologie)

Marseille, France

Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)

Montpellier, France

Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique)

Paris, France

Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique)

Strasbourg, France