Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

NCT07255508 | Not Yet Recruiting

• 2 other identifiers: APHP2500882025-A00926-43
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Benign Prostate Hypertrophy(BPH)

Keywords

Prostatic Artery Embolization; PAE; SQUIDPERI; Liquid Embolic Agent

Outcome Measures

Primary Outcomes (1)

• Clinical success at 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.

  Baseline and 3 months

Secondary Outcomes (20)

• Immediate technical success

  Embolization procedure (baseline)

• Clinical success at 6 months

  Baseline and 6 months

• Clinical success at 9 months

  Baseline and 9 months

• Clinical success at 12 months

  Baseline and 12 months

• IPSS at 3 months

  Baseline and 3 months

Study Arms (1)

Study group

Prostatic Artery Embolization

Device: Liquid embolic agent

Interventions

Liquid embolic agent DEVICE

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

Also known as: Squid Peri

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nonvulnerable men suffering from LUTS related to BPH and eligible to PAE.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Balt International: collaborator

Study Sites (4)

Hôpital Timone (Radiologie adultes et neuroradiologie)

Marseille, 13385, France

Location

Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)

Montpellier, 34295, France

Location

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

Paris, 75015, France

Location

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

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marc SAPOVAL

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touria EL AAMRI, Project manager

CONTACT

+33 (0)1 40 27 18 48; touria.el-aamri@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (4)