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Not yet recruiting NCT07255508

Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

— Observational Benign Prostate Hypertrophy(BPH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liquid embolic agent.
Who it may be relevant to
Registry conditions: Benign Prostate Hypertrophy(BPH). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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

Primary outcome measures

  • Clinical success at 3 months [Time frame: Baseline and 3 months]
Secondary outcome measures (12)
  • Immediate technical success [Time frame: Embolization procedure (baseline)]
  • Clinical success at 6 months [Time frame: Baseline and 6 months]
  • Clinical success at 9 months [Time frame: Baseline and 9 months]
  • Clinical success at 12 months [Time frame: Baseline and 12 months]
  • IPSS at 3 months [Time frame: Baseline and 3 months]
  • IPSS at 6 months [Time frame: Baseline and 6 months]
  • IPSS at 9 months [Time frame: Baseline and 9 months]
  • IPSS at 12 months [Time frame: Baseline and 12 months]
  • QoL at 3 months [Time frame: Baseline and 3 months]
  • QoL at 6 months [Time frame: Baseline and 6 months]
  • QoL at 9 months [Time frame: Baseline and 9 months]
  • QoL at 12 months [Time frame: Baseline and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • Hôpital Timone (Radiologie adultes et neuroradiologie) — Marseille
  • Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle) — Montpellier
  • Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et onco — Paris
  • Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnel — Strasbourg

Identifiers

NCT: NCT07255508 · APHP250088 · 2025-A00926-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗