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Embolization Agent

Prostatic Artery Embolization (HydroPearl® compressible microspheres) for Enlarged Prostate

N/A
Waitlist Available
Led By Clayton Commander, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following the procedure
Awards & highlights

Study Summary

This trial is testing whether a minimally invasive treatment for an enlarged prostate is as effective as medication, and if it has fewer side effects.

Eligible Conditions
  • Enlarged Prostate
  • Benign Prostatic Hyperplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in IPSS at 6 Months
Secondary outcome measures
Incidence of Treatment Related Adverse Events (Percent)
Incidence of Treatment Related Adverse Events (Proportion)
Prostate
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PAE ProcedureExperimental Treatment1 Intervention
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH)

Find a Location

Who is running the clinical trial?

Terumo Medical CorporationIndustry Sponsor
24 Previous Clinical Trials
10,416 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,650 Total Patients Enrolled
Clayton Commander, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

Enlarged Prostate Research Study Groups: PAE Procedure
Prostatic Artery Embolization (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04398966 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are there for this medical experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial began recruitment back in September of 2020 and is actively enrolling 30 patients at a single site as of June 13th 2022."

Answered by AI

Is enrollment in this experiment open to volunteers at the moment?

"Affirmative. Clinicaltrials.gov confirms that this medical research, which was launched on 23rd of September 2020, is still recruiting participants. To date, 30 people need to be recruited from a single medical facility."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Apr 2025