NCT02676544

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

5.6 years

First QC Date

January 17, 2016

Last Update Submit

July 2, 2021

Conditions

Benign Prostatic HypertrophyLower Urinary Tract Symptoms

Keywords

Prostate Artery Embolization (PAE)Benign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms (LUTS)PAEBPHLUTSProstate Artery EmbolizationEmbospheres

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)

    Questionnaire

    24 months

Secondary Outcomes (7)

  • Number of participants with treatment-related adverse events

    12 months

  • Change in peak urinary flow (Qmax)

    24 months

  • Change in prostate size

    24 months

  • Change in serum PSA from baseline

    24 months

  • Erectile and sexual function questionnaire

    24 months

  • +2 more secondary outcomes

Other Outcomes (7)

  • Procedural time in minutes

    1 day

  • Total fluoroscopy time in minutes

    1 day

  • Size of catheter used for embolization

    1 day

  • +4 more other outcomes

Study Arms (1)

Embosphere microspheres

EXPERIMENTAL

Embospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries.

Device: Embosphere microspheres

Interventions

Embosphere microspheresDEVICE

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.

Embosphere microspheres

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients selected for this study must meet all of the following criteria:
  • Age ≥ 50 years
  • Lower urinary tract symptoms secondary to BPH as defined by:
  • IPSS Symptom Index ≥ 12
  • Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
  • Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)

You may not qualify if:

  • Patients meeting any of the following criteria will be excluded from the study.
  • Age less than 50 years
  • Prostate cancer
  • Bladder cancer
  • Severe, life-threatening allergy to iodinated contrast
  • Bilateral internal iliac artery occlusion
  • Causes of obstruction other than BPH such as stricture disease
  • Neurogenic bladder or other causes of bladder atonia
  • Post void residual greater than 250 cc
  • Any contraindication to embolization, including
  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
  • Presence or likely onset of vasospasm
  • Presence or likely onset of hemorrhage
  • Presence of severe atheromatous disease
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

January 17, 2016

First Posted

February 8, 2016

Study Start

December 1, 2015

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Locations

US(1)