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Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

NCT02676544 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-07-08

No results posted yet for this study

Summary

This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.

Conditions

  • Benign Prostatic Hypertrophy
  • Lower Urinary Tract Symptoms

Interventions

DEVICE

Embosphere microspheres

This is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size ≥90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676544 on ClinicalTrials.gov