Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia (EmboProstate)

Jena University Hospital

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Embozene Microspheres

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02206243

3952-12/13

Details and patient eligibility

About

The purpose of this observational study is to evaluate the prostatic arterial embolization (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (BPH).

Full description

EmboProstate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. If eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. Once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by BPH. Within one week after PAE as well as after one, three and six months post-procedure an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.

Enrollment: 300 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male
• adults > 40 years old
• severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate (Qmax) ≤ 15 ml/sec or transurethral catheter for retention
• no improvement after or intolerance of medical treatment for at least six months
• prostatic volume > 30 cm³

Exclusion criteria

• female
• less than 40 years old
• eGFR < 45 ml/min * m²
• suspicion of prostatic malignancy
• prostatic malignancy
• acute prostatitis or cystitis
• hydronephrosis
• bladder stone or bladder diverticulum
• urethral stenosis
• major surgery within 4 weeks prior to the screening visit
• active clinically serious infection
• progressive arteriosclerosis
• contraindications against angiography

Trial design

300 participants in 1 patient group

Embozene

Description:

Patients receiving Embozene microspheres

Treatment:

Drug: Embozene Microspheres