Benign Prostatic HyperplasiaEMBOLICOLNCT06678308
Comparison of Glue with Microparticles in Prostatic Artery Embolization
A study testing Embolisation with Magic Glue® and Embolisation with Embosphere® in people with Benign Prostatic Hyperplasia, run by Almaviva Sante at 1 site in France.
Trial summary
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Embolisation with Magic Glue® and Embolisation with Embosphere®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 31 May 2027
- Phase
- Interventional
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient aged ≥ 50 years and ≤ 80 years
- Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry < 15 ml/s).
- Patient failing or intolerant to drug treatment (tadalafil and/or one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).
Who cannot join
- Patient with advanced and complicated BPH on renal and bladder ultrasound:
- Severe obstruction related bladder wall lesions : >3 micro-diverticula or single or multiple diverticula with a sac diameter > 10 mm.
- Chronic dilatation of the excretory cavities : diameter of one or both pyelons >15 mm.
- Patient with suspected prostate or bladder cancer on MRI
- Patients with moderate or severe chronic renal failure, with creatinine clearance < 40 ml/min.
- Patient with prostate or bladder cancer diagnosed by biopsy in the 6 months preceding the inclusion visit.
- Patient with an active urinary tract infection
- Patient already included and participating in another clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique de l'Alma
Paris, Paris, 75007
Grégory AMOUYAL, MD, +33 6 80 70 40 40, dr.gregory.amouyal@gmail.com
About this study
Official title: Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy.
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
Read more
The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Read the detailed description
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent, used by the majority of expert prostate embolisation teams, is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embolisation with Magic Glue®, Embolisation with Embosphere®
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolisation with Magic Glue®Device
Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
Embolisation with Embosphere®Device
Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland
| Study group | Role | What they receive |
|---|---|---|
| Magic Glue® | Experimental | Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol Receives: Device: Embolisation with Magic Glue® |
| Embosphere® | Active comparator | Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®) Receives: Device: Embolisation with Embosphere® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of embolisation
Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).
Measured: Month 3
Secondary outcomes (9)
Post-Mictional Residue
Post-Mictional Residue will be assessed will be measured in ml by ultrasound
Measured: Month 1, Month 3 and Month 12
Prostatic infarct areas
Prostatic infarct areas will be measured in mm3 on MRI
Measured: Month 3
Sexual function
Sexual function will be assessed with IIEF5 questionnaire (International Index of Erectile Function form 5) (0 - 25 points). Score lower than 10 means severe erectile dysfunction whereas score higher than 20 means normal erectile function.
Measured: Month 1, Month 3 and Month 12
Patient quality of life
Patient quality of life will be assessed with IPSS quality of life question (1 - 7). 1 means patient is very satisfied of his/her quality of life
Measured: Month 1, Month 3 and Month 12
Prostatic Serum Antigen
Prostatic Serum Antigen (PSA) will be measured from blood sample. Normal value should be lower than 4 ng/ml
Measured: Month 1, Month 3 and Month 12
Urinary flow
Urinary flow will be measured in ml/s by flow measurement
Measured: Month 1, Month 3 and Month 12
Prostatic volume
Prostatic volume will be in ml on MRI
Measured: Month 3 and Month 12
Efficacy of embolisation
Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).
Measured: Month 1 and Month 12
Safety of embolisation
Safety of embolisation will be assessed with post-empbolisation symptoms description and other adverse events description
Measured: Day 15, Month 3 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almaviva Sante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégory AMOUYAL, MD, Principal investigator, Clinique de l'Alma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678308
- Sponsor's protocol ID
- 2023-08
- Other IDs
- ID-RCB number: 2024-A01753-44
- Acronym
- EMBOLICOL
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.
- ClinicalTrials.gov ID
- NCT06678308
- Acronym / sponsor ID
- EMBOLICOL / 2023-08
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Almaviva SanteUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Nov 2024 (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 embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy.
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Detailed description
Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).
The principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.
The reference embolisation agent, used by the majority of expert prostate embolisation teams, is a suspension of calibrated trisacryl microparticles 300-500 microns in size.
Recently, the use of glue has been retrospectively studied with acceptable efficacy and safety (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.
In this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magic Glue® | Experimental | Device: Embolisation with Magic Glue®Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol |
| Embosphere® | Active comparator | Device: Embolisation with Embosphere®Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patient aged ≥ 50 years and ≤ 80 years
- Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry < 15 ml/s).
- Patient failing or intolerant to drug treatment (tadalafil and/or one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).
Key exclusion criteria (8 listed)
- Patient with advanced and complicated BPH on renal and bladder ultrasound:
- Severe obstruction related bladder wall lesions : >3 micro-diverticula or single or multiple diverticula with a sac diameter > 10 mm.
- Chronic dilatation of the excretory cavities : diameter of one or both pyelons >15 mm.
- Patient with suspected prostate or bladder cancer on MRI
- Patients with moderate or severe chronic renal failure, with creatinine clearance < 40 ml/min.
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 |
|---|---|---|
| Embolisation with Magic Glue®Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland | Device | Magic Glue® |
| Embolisation with Embosphere®Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland | Device | Embosphere® |
Primary outcome
Efficacy of embolisation
Time frame: Month 3
Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).
9 secondary outcomes
Post-Mictional Residue
Time frame: Month 1, Month 3 and Month 12
Prostatic infarct areas
Time frame: Month 3
Sexual function
Time frame: Month 1, Month 3 and Month 12
Patient quality of life
Time frame: Month 1, Month 3 and Month 12
Prostatic Serum Antigen
Time frame: Month 1, Month 3 and Month 12
Urinary flow
Time frame: Month 1, Month 3 and Month 12
Prostatic volume
Time frame: Month 3 and Month 12
Efficacy of embolisation
Time frame: Month 1 and Month 12
Safety of embolisation
Time frame: Day 15, Month 3 and Month 12
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 7 Nov 2024.
- 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.
Grégory AMOUYAL, MD principal investigator
Clinique de l'Alma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolisation with Magic Glue® and Embolisation with Embosphere® in people with Benign Prostatic Hyperplasia, run by Almaviva Sante 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 3 inclusion and 8 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 7 Nov 2024. 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?
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 Grégory AMOUYAL, MD (+ 33 6 80 70 40 40, dr.gregory.amouyal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of embolisation (time frame: Month 3). 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 7 Nov 2024.