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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 6 months, 12 months
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 moreOther 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
1,427 Previous Clinical Trials
1,620,553 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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: GAE + Standard of Care
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04456569 — N/A
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