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Clinical Trials in France / NCT07255508
Starting soon Observational

Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

NCT07255508 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-11
Last updated
2025-12-01

Condition(s) studied

Benign Prostate Hypertrophy(BPH)

Investigational drug(s) / intervention(s)

Liquid embolic agent

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Patient scheduled for a PAE using SquidPERI as part of routine care * Patient informed who signed the informed consent form * French social security affiliation * Good understanding of the French language Exclusion Criteria: * Patient unwilling or unlikely to comply with FU schedule * Known severe allergy to iodine * Known severe hepatic impairment * Vulnerable patient populations (such as patient under guardianship, curatorship, deprived of liberty) * Patient that already had a PAE * Patient on AME (state medical aid) * Participation in any interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable

Primary outcome measure(s)

  • Clinical success at 3 months — Baseline and 3 months
    Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1.

Trial sites (4)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07255508 on ClinicalTrials.gov ↗ ← All trials in France