Efficacy of Prostatic Arteries Embolization Using SQUIDPERI (SQUID-PAE)

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Benign Prostate Hypertrophy(BPH)

Treatments

Device: Liquid embolic agent

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07255508

2025-A00926-43 (Other Identifier)

APHP250088

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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