Benign Prostatic HyperplasiaPAE CEUSNCT04267445
Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS)
An observational study of Benign Prostatic Hyperplasia, run by University of Calgary.
Trial summary
A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Embolization of prostatic artery under ultrasound guidance
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men over 50 who have been diagnosed with benign prostatic hyperplasia and their prostates are larger than 40 cm3.
Who may be able to join
- Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -
- Have received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
- Are greater than 50 years of age
- Have had a pelvic examination by a urologist within the previous 6 months
- Have been refractory to medical therapy for 6 months, or have refused medical therapy
- Have a Qmax below 15 mL/s or acute urinary retention
- Prostate larger than 40 cm3
- Willing and able to provide written informed consent.
Who cannot join
- Patients will be excluded from this study if they meet any of the following criteria:
- Total serum PSA > 10.0 ng/mL at screening
- Advanced atherosclerosis and tortuosity of the iliac arteries
- PVR > 250 mL
- Use of phytotherapy for BPH within 2 weeks of screening visit
- Secondary renal insufficiency (due to prostatic obstruction)
Show all 15Show fewer
- Chronic renal failure (glomerular filtration rate < 60)
- Large bladder diverticula or bladder stones
- Have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies, including but not confined to the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, or permanent hearing aids
- Have compromised hematopoietic function (hemoglobin < 100 g/L; lymphocyte count < 500 x106/L; neutrophil count < 1.5 x 109/L; platelet count < 50 x 109/L
- Have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids
- Have received other investigational drugs or who have had experimental therapy within the past 4 weeks or are participating in any other concurrent experimental therapy
- Have abnormal coagulation profiles
- Are allergic to bovine collagen
- Are allergic to Perflutren 15 Are unable to comply with the follow up requirements of the study 16 Have serious cardiopulmonary compromise
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Single Centre Study to Evaluate the Safety and Effectiveness of Using Contrast Enhanced Ultrasound and Echogenic Embolic Agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy
A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia
Read the detailed description
Single center, open label, pilot study. After screening and baseline testing, eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure.
After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients. Patients will be enrolled until 15 patients have undergone treatment. The patients will undergo MRI, contrast enhanced ultrasound and computerized tomography (CT) angiograpy/intra-procedural cone beam CT as required.
Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.
Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embolization of prostatic artery under ultrasound guidance
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of prostatic artery under ultrasound guidanceProcedure or surgery
Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.
| Study group | Role | What they receive |
|---|---|---|
| Embolization patients | Single center, open label, pilot study. Eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure.
After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients.
Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.
Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software. Receives: Procedure: Embolization of prostatic artery under ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensions of prostate
Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique
Measured: One year
Symptoms of benign prostate hyperplasia
Evaluate the efficacy of using contrast enhanced ultrasound and echogenic embolization agent Ekobi Embolization Microspheres on International Prostate Symptom Score (IPSS).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2023 (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.
- More trials run by University of CalgaryThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- IMBiotechnologies Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267445
- Sponsor's protocol ID
- REB19-0963
- Acronym
- PAE CEUS
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Centre Study to Evaluate the Safety and Effectiveness of Using Contrast Enhanced Ultrasound and Echogenic Embolic Agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy
- ClinicalTrials.gov ID
- NCT04267445
- Acronym / sponsor ID
- PAE CEUS / REB19-0963
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- IMBiotechnologies Ltd.
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Feb 2020 (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.
A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia
Detailed description
Single center, open label, pilot study. After screening and baseline testing, eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure.
After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients. Patients will be enrolled until 15 patients have undergone treatment. The patients will undergo MRI, contrast enhanced ultrasound and computerized tomography (CT) angiograpy/intra-procedural cone beam CT as required.
Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.
Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization patients | – | Procedure: Embolization of prostatic artery under ultrasound guidanceSingle center, open label, pilot study. Eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure. After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients. Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization. Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men over 50 who have been diagnosed with benign prostatic hyperplasia and their prostates are larger than 40 cm3.
Key inclusion criteria (8 listed)
- Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -
Key exclusion criteria (15 listed)
- Patients will be excluded from this study if they meet any of the following criteria:
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 |
|---|---|---|
| Embolization of prostatic artery under ultrasound guidanceEkobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization. | Procedure or surgery | Embolization patients |
Primary outcome
Dimensions of prostate
Time frame: One year
Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique
Symptoms of benign prostate hyperplasia
Time frame: One year
Evaluate the efficacy of using contrast enhanced ultrasound and echogenic embolization agent Ekobi Embolization Microspheres on International Prostate Symptom Score (IPSS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by University of Calgary.
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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darshan Bakshi, MD (4039919257, darshan.bakshi@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensions of prostate (time frame: One year). The study lists 2 primary outcomes in all. 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 17 Feb 2020.