Benign Prostate Hypertrophy(BPH)SQUID-PAENCT07255508
Efficacy of Prostatic Arteries Embolization Using SQUIDPERI
An observational study of Benign Prostate Hypertrophy(BPH), run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Liquid embolic agent
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2025to Nov 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Nonvulnerable men suffering from LUTS related to BPH and eligible to PAE.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Hôpital Timone (Radiologie adultes et neuroradiologie)
Marseille, 13385
Vincent VIDAL, +33 (0) 4 13 42 90 60, vincent.vidal@ap-hm.fr
Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)
Montpellier, 34295
Hélène KOVACSIK, +33 (0) 4 67 33 60 00, h-vernhet@chu-montpellier.fr
Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique)
Paris, 75015
Marc SAPOVAL, +33 (0) 1 56 09 37 40, marc.sapoval2@aphp.fr
Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique)
Strasbourg, 67000
Gilles GOYAULT, +33 (0) 3 90 67 39 91, g.goyault@ics.clinique-rhena.fr
About this study
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)
- Being tested
- Liquid embolic agent
- Keywords
- Prostatic Artery Embolization, PAE, SQUIDPERI, Liquid Embolic Agent
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid embolic agentDevice
Also called Squid Peri
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Prostatic Artery Embolization Receives: Device: Liquid embolic agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (20)
Immediate technical success
Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI.
Measured: Embolization procedure (baseline)
Clinical success at 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.
Measured: Baseline and 6 months
Clinical success at 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.
Measured: Baseline and 9 months
Clinical success at 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.
Measured: Baseline and 12 months
IPSS at 3 months
Change in IPSS score and subscores compared to baseline.
Measured: Baseline and 3 months
IPSS at 6 months
Change in IPSS score and subscores compared to baseline.
Measured: Baseline and 6 months
IPSS at 9 months
Change in IPSS score and subscores compared to baseline.
Measured: Baseline and 9 months
IPSS at 12 months
Change in IPSS score and subscores compared to baseline.
Measured: Baseline and 12 months
QoL at 3 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Measured: Baseline and 3 months
QoL at 6 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Measured: Baseline and 6 months
QoL at 9 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Measured: Baseline and 9 months
QoL at 12 months
Change in QoL score (last question of IPSS questionnaire) compared to baseline.
Measured: Baseline and 12 months
IIEF-15 at 3 months
Change in IIEF-15 score and subscores compared to baseline.
Measured: Baseline and 3 months
IIEF-15 at 6 months
Change in IIEF-15 score and subscores compared to baseline.
Measured: Baseline and 6 months
IIEF-15 at 9 months
Change in IIEF-15 score and subscores compared to baseline.
Measured: Baseline and 9 months
IIEF-15 at 12 months
Change in IIEF-15 score and subscores compared to baseline.
Measured: Baseline and 12 months
Adverse events and serious adverse events
Number of adverse events and serious adverse events.
Measured: Up to 12 months
Benign prostatic hyperplasia medication at baseline
Number of benign prostatic hyperplasia medication.
Measured: Baseline
Benign prostatic hyperplasia medication at 3 months
Number of benign prostatic hyperplasia medication.
Measured: 3 months
Re-intervention for benign prostatic hyperplasia at 12 months
Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Balt International
- Responsible party
- Sponsor
- Investigators
- Marc SAPOVAL, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255508
- Sponsor's protocol ID
- APHP250088
- Other IDs
- 2025-A00926-43
- Acronym
- SQUID-PAE
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prostatic Arteries Embolization Using SQUIDPERI
- ClinicalTrials.gov ID
- NCT07255508
- Acronym / sponsor ID
- SQUID-PAE / APHP250088
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Keywords
- Prostatic Artery Embolization, PAE, SQUIDPERI, Liquid Embolic Agent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Balt International
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Liquid embolic agentProstatic Artery Embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nonvulnerable men suffering from LUTS related to BPH and eligible to PAE.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid embolic agentAlso: Squid PeriProstatic 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 | Device | Study group |
Primary outcome
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.
20 secondary outcomes
Immediate technical success
Time frame: Embolization procedure (baseline)
Clinical success at 6 months
Time frame: Baseline and 6 months
Clinical success at 9 months
Time frame: Baseline and 9 months
Clinical success at 12 months
Time frame: Baseline and 12 months
IPSS at 3 months
Time frame: Baseline and 3 months
IPSS at 6 months
Time frame: Baseline and 6 months
IPSS at 9 months
Time frame: Baseline and 9 months
IPSS at 12 months
Time frame: Baseline and 12 months
QoL at 3 months
Time frame: Baseline and 3 months
QoL at 6 months
Time frame: Baseline and 6 months
QoL at 9 months
Time frame: Baseline and 9 months
QoL at 12 months
Time frame: Baseline and 12 months
IIEF-15 at 3 months
Time frame: Baseline and 3 months
IIEF-15 at 6 months
Time frame: Baseline and 6 months
IIEF-15 at 9 months
Time frame: Baseline and 9 months
IIEF-15 at 12 months
Time frame: Baseline and 12 months
Adverse events and serious adverse events
Time frame: Up to 12 months
Benign prostatic hyperplasia medication at baseline
Time frame: Baseline
Benign prostatic hyperplasia medication at 3 months
Time frame: 3 months
Re-intervention for benign prostatic hyperplasia at 12 months
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc SAPOVAL principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH), run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Touria EL AAMRI, Project manager (+33 (0)1 40 27 18 48, touria.el-aamri@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success at 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.