Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostate Hypertrophy(BPH)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Prostatic Artery Embolization

Liquid embolic agent

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Squid Peri

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No