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Trial record 4 of 4 for:    imbiotechnologies

Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS) (PAE CEUS)

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ClinicalTrials.gov Identifier: NCT04267445
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
IMBiotechnologies Ltd.
Information provided by (Responsible Party):
University of Calgary

Brief 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

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: Embolization of prostatic artery under ultrasound guidance

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Procedure: Embolization of prostatic artery under ultrasound guidance
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.




Primary Outcome Measures :
  1. Dimensions of prostate [ Time Frame: One year ]
    Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men have benign prostatic hyperplasia
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men over 50 who have been diagnosed with benign prostatic hyperplasia and their prostates are larger than 40 cm3.
Criteria

Inclusion Criteria:

  • Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -

    1. Have received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
    2. Are greater than 50 years of age
    3. Have had a pelvic examination by a urologist within the previous 6 months
    4. Have been refractory to medical therapy for 6 months, or have refused medical therapy
    5. Have a Qmax below 15 mL/s or acute urinary retention
    6. Prostate larger than 40 cm3
    7. Willing and able to provide written informed consent.

Exclusion Criteria:

  • Patients will be excluded from this study if they meet any of the following criteria:

    1. Total serum PSA > 10.0 ng/mL at screening
    2. Advanced atherosclerosis and tortuosity of the iliac arteries
    3. PVR > 250 mL
    4. Use of phytotherapy for BPH within 2 weeks of screening visit
    5. Secondary renal insufficiency (due to prostatic obstruction)
    6. Chronic renal failure (glomerular filtration rate < 60)
    7. Large bladder diverticula or bladder stones
    8. 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
    9. 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
    10. 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
    11. 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
    12. Have abnormal coagulation profiles
    13. Are allergic to bovine collagen
    14. Are allergic to Perflutren 15 Are unable to comply with the follow up requirements of the study 16 Have serious cardiopulmonary compromise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267445


Contacts
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Contact: Darshan Bakshi, MD 4039919257 darshan.bakshi@ahs.ca
Contact: Clare Russell 4039442515 clare.russell@ahs.ca

Sponsors and Collaborators
University of Calgary
IMBiotechnologies Ltd.
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04267445    
Other Study ID Numbers: REB19-0963
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases