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NCT Number: NCT07255508

Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

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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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital Timone (Radiologie adultes et neuroradiologie), Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Squid Peri

Primary outcomes

  1. Clinical success at 3 months

    Time frame: 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.

Secondary outcomes

  1. Immediate technical success

    Time frame: Embolization procedure (baseline)

    Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI.

  2. Clinical success at 6 months

    Time frame: Baseline and 6 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.

  3. Clinical success at 9 months

    Time frame: Baseline and 9 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.

  4. Clinical success at 12 months

    Time frame: Baseline and 12 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.

  5. IPSS at 3 months

    Time frame: Baseline and 3 months

    Change in IPSS score and subscores compared to baseline.

  6. IPSS at 6 months

    Time frame: Baseline and 6 months

    Change in IPSS score and subscores compared to baseline.

  7. IPSS at 9 months

    Time frame: Baseline and 9 months

    Change in IPSS score and subscores compared to baseline.

  8. IPSS at 12 months

    Time frame: Baseline and 12 months

    Change in IPSS score and subscores compared to baseline.

  9. QoL at 3 months

    Time frame: Baseline and 3 months

    Change in QoL score (last question of IPSS questionnaire) compared to baseline.

  10. QoL at 6 months

    Time frame: Baseline and 6 months

    Change in QoL score (last question of IPSS questionnaire) compared to baseline.

  11. QoL at 9 months

    Time frame: Baseline and 9 months

    Change in QoL score (last question of IPSS questionnaire) compared to baseline.

  12. QoL at 12 months

    Time frame: Baseline and 12 months

    Change in QoL score (last question of IPSS questionnaire) compared to baseline.

  13. IIEF-15 at 3 months

    Time frame: Baseline and 3 months

    Change in IIEF-15 score and subscores compared to baseline.

  14. IIEF-15 at 6 months

    Time frame: Baseline and 6 months

    Change in IIEF-15 score and subscores compared to baseline.

  15. IIEF-15 at 9 months

    Time frame: Baseline and 9 months

    Change in IIEF-15 score and subscores compared to baseline.

  16. IIEF-15 at 12 months

    Time frame: Baseline and 12 months

    Change in IIEF-15 score and subscores compared to baseline.

  17. Adverse events and serious adverse events

    Time frame: Up to 12 months

    Number of adverse events and serious adverse events.

  18. Benign prostatic hyperplasia medication at baseline

    Time frame: Baseline

    Number of benign prostatic hyperplasia medication.

  19. Benign prostatic hyperplasia medication at 3 months

    Time frame: 3 months

    Number of benign prostatic hyperplasia medication.

  20. Re-intervention for benign prostatic hyperplasia at 12 months

    Time frame: Up to 12 months

    Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization).

Study contacts

Contact information is provided by the study sponsor or research team.

Touria EL AAMRI, Project manager

CONTACT

[email protected]

+33 (0)1 40 27 18 48

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Balt International

Registry information

Acronym: SQUID-PAE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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