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Assistance Publique - Hôpitaux de ParisEfficacy of Prostatic Arteries Embolization Using SQUIDPERI (SQUID-PAE)
Clinical Trial NCT07255508 (SQUID-PAE) is an observational study for Benign Prostate Hypertrophy(BPH) is not yet recruiting. Enrollment is planned to begin on 1 November 2025 until the trial accrues 100 participants. Led by Assistance Publique - Hôpitaux de Paris, this trial is expected to complete by 1 November 2027. The latest data from ClinicalTrials.gov was last updated on 1 December 2025.
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.
Official Title
Efficacy of Prostatic Arteries Embolization Using SQUIDPERI
Conditions
Benign Prostate Hypertrophy(BPH)Other Study IDs
- SQUID-PAE
- APHP250088
- 2025-A00926-43 (Other Identifier) (ANSM (French National Agency for the Safety of Medicines and Health Products))
NCT ID Number
Start Date (Actual)
2025-11
Last Update Posted
2025-12-01
Completion Date (Estimated)
2027-11
Enrollment (Estimated)
100
Study Type
Observational
Status
Not yet recruiting
Keywords
Prostatic Artery Embolization
PAE
SQUIDPERI
Liquid Embolic Agent
PAE
SQUIDPERI
Liquid Embolic Agent
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Study group Prostatic Artery Embolization | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | Baseline and 12 months |
IPSS at 3 months | Change in IPSS score and subscores compared to baseline. | Baseline and 3 months |
IPSS at 6 months | Change in IPSS score and subscores compared to baseline. | Baseline and 6 months |
IPSS at 9 months | Change in IPSS score and subscores compared to baseline. | Baseline and 9 months |
IPSS at 12 months | Change in IPSS score and subscores compared to baseline. | Baseline and 12 months |
QoL at 3 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 3 months |
QoL at 6 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 6 months |
QoL at 9 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 9 months |
QoL at 12 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 12 months |
IIEF-15 at 3 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 3 months |
IIEF-15 at 6 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 6 months |
IIEF-15 at 9 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 9 months |
IIEF-15 at 12 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 12 months |
Adverse events and serious adverse events | Number of adverse events and serious adverse events. | Up to 12 months |
Benign prostatic hyperplasia medication at baseline | Number of benign prostatic hyperplasia medication. | Baseline |
Benign prostatic hyperplasia medication at 3 months | Number of benign prostatic hyperplasia medication. | 3 months |
Re-intervention for benign prostatic hyperplasia at 12 months | Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization). | Up to 12 months |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
- 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
- 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
Assistance Publique - Hôpitaux de Paris961 active trials to exploreBalt InternationalStudy Central Contact
Contact: Touria EL AAMRI, Project manager, +33 (0)1 40 27 18 48, [email protected]
4 Study Locations in 1 Countries
Hôpital Timone (Radiologie adultes et neuroradiologie), Marseille, 13385, France
Vincent VIDAL, Contact, +33 (0) 4 13 42 90 60, [email protected]
Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle), Montpellier, 34295, France
Hélène KOVACSIK, Contact, +33 (0) 4 67 33 60 00, [email protected]
Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique), Paris, 75015, France
Marc SAPOVAL, Contact, +33 (0) 1 56 09 37 40, [email protected]
Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique), Strasbourg, 67000, France
Gilles GOYAULT, Contact, +33 (0) 3 90 67 39 91, [email protected]