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

November 20, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Marseille, France, 13385
        • Hôpital Timone (Radiologie adultes et neuroradiologie)
        • Contact:
      • Montpellier, France, 34295
        • Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)
        • Contact:
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique)
        • Contact:
      • Strasbourg, France, 67000
        • Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study group
Prostatic Artery Embolization
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
Other Names:
  • Squid Peri

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Embolization procedure (baseline)
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.
Baseline and 6 months
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.
Baseline and 9 months
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.
Baseline and 12 months
IPSS at 3 months
Time Frame: Baseline and 3 months
Change in IPSS score and subscores compared to baseline.
Baseline and 3 months
IPSS at 6 months
Time Frame: Baseline and 6 months
Change in IPSS score and subscores compared to baseline.
Baseline and 6 months
IPSS at 9 months
Time Frame: Baseline and 9 months
Change in IPSS score and subscores compared to baseline.
Baseline and 9 months
IPSS at 12 months
Time Frame: Baseline and 12 months
Change in IPSS score and subscores compared to baseline.
Baseline and 12 months
QoL at 3 months
Time Frame: Baseline and 3 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Baseline and 3 months
QoL at 6 months
Time Frame: Baseline and 6 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Baseline and 6 months
QoL at 9 months
Time Frame: Baseline and 9 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Baseline and 9 months
QoL at 12 months
Time Frame: Baseline and 12 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Baseline and 12 months
IIEF-15 at 3 months
Time Frame: Baseline and 3 months
Change in IIEF-15 score and subscores compared to baseline.
Baseline and 3 months
IIEF-15 at 6 months
Time Frame: Baseline and 6 months
Change in IIEF-15 score and subscores compared to baseline.
Baseline and 6 months
IIEF-15 at 9 months
Time Frame: Baseline and 9 months
Change in IIEF-15 score and subscores compared to baseline.
Baseline and 9 months
IIEF-15 at 12 months
Time Frame: Baseline and 12 months
Change in IIEF-15 score and subscores compared to baseline.
Baseline and 12 months
Adverse events and serious adverse events
Time Frame: Up to 12 months
Number of adverse events and serious adverse events.
Up to 12 months
Benign prostatic hyperplasia medication at baseline
Time Frame: Baseline
Number of benign prostatic hyperplasia medication.
Baseline
Benign prostatic hyperplasia medication at 3 months
Time Frame: 3 months
Number of benign prostatic hyperplasia medication.
3 months
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).
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Balt International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc SAPOVAL, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP250088
  • 2025-A00926-43 (Other Identifier: ANSM (French National Agency for the Safety of Medicines and Health Products))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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