Prostatic Hyperplasia, BenignSQUIDNCT05395299
Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )
A study testing SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization in people with Prostatic Hyperplasia, Benign, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid) Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign
- What is being tested?
- SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to 5 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 45 and under 80
- Benign prostatic hypertrophy with an obstructive syndrome of the lower urinary tract intolerant or refractory to medical treatment (continued for 6 months)
- Indication of prostatic embolization.
- Prostate volume of more than 40 ml
- Subject with an IPSS> 18 and a Qol> 3
- Affiliation to a social security scheme.
Show all 23Show fewer
- Subject who has given informed consent to participate in the study.
- Exclusion criteria patient with prostate cancer or suspected of having prostate cancer
- patient with neurological bladder or AUS of extra-prostatic origin
- detrusor dysfunction
- documented allergy to iodinated contrast media
- Hepatic insufficiency
- advanced arteritis
- severe renal failure with glomerular filtration rate <60 ml / min / 1.73 m2 body surface area
- inability to independently complete the self-questionnaires used in the study • acute or chronic prostatitis
- hydronephrosis
- diverticulum larger than 2 cm or bladder calculus
- ureteral stenosis
- active infectious syndrome
- major surgery in the four months preceding the inclusion visit
- Progressive cancer or for which the risk of progressive recovery is more than 50% in the next 5 years
- limited life expectancy
- Vulnerable persons defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (eg: persons deprived of their liberty, minors, protected adults, etc.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients With Benign Prostatic Hyperplasia: Monocentric Pilot Study
The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)
Read the detailed description
Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.
- Conditions
- Prostatic Hyperplasia, Benign
- Being tested
- SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial EmbolizationProcedure or surgery
Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) | Experimental | Injection at the level of the right and left prostate arteries of Squid until a complete occlusion of these arteries, and a filling of their intraprostatic branches Receives: Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to study the feasibility of prostate embolization with SQUID
squid injection success in the prostate assessed by a scanner
Measured: day 0
Secondary outcomes (1)
Description of the causes of technical embolization failures
Injection into the 2 prostate lobes
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start22 Nov 2022
- Primary completion22 Nov 2023
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395299
- Sponsor's protocol ID
- 21-PP-21
- Other IDs
- 2021-A02956-35
- Acronym
- SQUID
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedat J, Fontas E, Arnoffi P, Stranieri G, Colomb F, Chau Y. Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis. Cardiovasc Intervent Radiol. 2025 Sep;48(9):1369-1375. doi: 10.1007/s00270-025-04164-x. Epub 2025 Aug 13.
PubMed 40804546Sedat J, Arnoffi P, Poirier F, Jamjoom M, Raffaelli C, Colomb F, Chau Y. Non-target embolic events during prostatic embolization with ethylene vinyl alcohol copolymer (EVOH). CVIR Endovasc. 2023 Nov 3;6(1):54. doi: 10.1186/s42155-023-00402-w.
PubMed 37922055
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients With Benign Prostatic Hyperplasia: Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT05395299
- Acronym / sponsor ID
- SQUID / 21-PP-21
- Conditions
- Prostatic Hyperplasia, Benign
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 27 May 2022 (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.
The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)
Detailed description
Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) | Experimental | Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial EmbolizationInjection at the level of the right and left prostate arteries of Squid until a complete occlusion of these arteries, and a filling of their intraprostatic branches |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient over 45 and under 80
- Benign prostatic hypertrophy with an obstructive syndrome of the lower urinary tract intolerant or refractory to medical treatment (continued for 6 months)
- Indication of prostatic embolization.
- Prostate volume of more than 40 ml
- Affiliation to a social security scheme.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial EmbolizationProstatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) | Procedure or surgery | Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) |
Primary outcome
The main objective is to study the feasibility of prostate embolization with SQUID
Time frame: day 0
squid injection success in the prostate assessed by a scanner
1 secondary outcome
Description of the causes of technical embolization failures
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 40804546Sedat J, Fontas E, Arnoffi P, Stranieri G, Colomb F, Chau Y. Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis. Cardiovasc Intervent Radiol. 2025 Sep;48(9):1369-1375. doi: 10.1007/s00270-025-04164-x. Epub 2025 Aug 13.
- Derived from this study: PubMed 37922055Sedat J, Arnoffi P, Poirier F, Jamjoom M, Raffaelli C, Colomb F, Chau Y. Non-target embolic events during prostatic embolization with ethylene vinyl alcohol copolymer (EVOH). CVIR Endovasc. 2023 Nov 3;6(1):54. doi: 10.1186/s42155-023-00402-w.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization in people with Prostatic Hyperplasia, Benign, run by Centre Hospitalier Universitaire de Nice at 1 site 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 23 inclusion and 0 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective is to study the feasibility of prostate embolization with SQUID (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395299, which also lists 2 linked publications.
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 24 Feb 2025.