Status:
COMPLETED
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Brief Summary
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 symptoma...
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02206243
Start Date
September 1 2014
End Date
February 1 2019
Last Update
June 14 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Radiology, University Hospital Jena
Jena, Thuringia, Germany, 07740