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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00926-43 | Other Identifier | ANSM (French National Agency for the Safety of Medicines and Health Products) |
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| Name | Class |
|---|---|
| Balt International | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Prostatic Artery Embolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Nonvulnerable men suffering from LUTS related to BPH and eligible to PAE.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Touria EL AAMRI, Project manager | Contact | +33 (0)1 40 27 18 48 | touria.el-aamri@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marc SAPOVAL | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Timone (Radiologie adultes et neuroradiologie) | Marseille | 13385 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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 |
| Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle) | Montpellier | 34295 | France |
|
| Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique) | Paris | 75015 | France |
|
| Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique) | Strasbourg | 67000 | France |
|
| D052801 |
| Male Urogenital Diseases |