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Vascular Embolization

Geniculate Artery Embolization for Osteoarthritis

N/A
Recruiting
Led By Jafar Golzarian, MD
Research Sponsored by University of Minnesota
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 baseline, 1 month, 6 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat osteoarthritis that doesn't involve surgery. They will compare it to the standard of care to see if it is better.

Who is the study for?
This trial is for people with mild to moderate knee osteoarthritis who haven't improved after at least 3 months of treatments like anti-inflammatory drugs or physical therapy. They should be under 250 pounds, not planning on knee replacement surgery soon, and able to get an MRI before and after the procedure. People can't join if they're over 250 pounds, have certain heart or blood conditions, severe allergies to iodine, are pregnant, or have had certain knee surgeries.
What is being tested?
The study tests geniculate artery embolization (a minimally invasive procedure that blocks abnormal blood vessels) plus standard care against standard care alone in managing knee osteoarthritis symptoms. It aims to see if this treatment can control symptoms better and slow down disease progression.
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, bruising or bleeding there as well. There's also a risk of non-target embolization where other areas might accidentally be blocked off leading to tissue damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as Assessed by Grade 3-4 Adverse events
Secondary study objectives
C-Reactive Protein Concentration
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
+5 more
Other study objectives
Feasibility as Assessed by Protocol Adherence
Feasibility as Assessed by Recruitment Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GAE + Standard of CareExperimental Treatment1 Intervention
Participants in this arm will receive geniculate artery embolization and standard of care.
Group II: Standard of CareActive Control1 Intervention
Participants in this arm will receive standard of care only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Geniculate Artery Embolization
2018
N/A
~50

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,623 Total Patients Enrolled
4 Trials studying Osteoarthritis
152 Patients Enrolled for Osteoarthritis
Jafar Golzarian, MDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
379 Total Patients Enrolled
Reza Talaie, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Geniculate Artery Embolization (Vascular Embolization) Clinical Trial Eligibility Overview. Trial Name: NCT04456569 — N/A
Osteoarthritis Research Study Groups: GAE + Standard of Care, Standard of Care
Osteoarthritis Clinical Trial 2023: Geniculate Artery Embolization Highlights & Side Effects. Trial Name: NCT04456569 — N/A
Geniculate Artery Embolization (Vascular Embolization) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04456569 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04456569 — N/A
~6 spots leftby Feb 2026
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