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Arterial Embolization
Genicular Artery Embolization for Knee Osteoarthritis
N/A
Recruiting
Led By Andrew C Picel, MD
Research Sponsored by Andrew Picel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ineligibility or refusal of surgical management.
Ineligibility or refusal of surgical management
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post gae
Awards & highlights
Study Summary
This trial is testing whether a procedure to block abnormal blood vessels caused by knee arthritis is safe and effective in reducing knee pain.
Who is the study for?
This trial is for adults over 40 with moderate to severe knee pain due to osteoarthritis, who haven't found relief from anti-inflammatory meds, physical therapy, or injections. They should have certain MRI features of active synovitis and not be candidates for surgery. People with life-threatening allergies to iodine, recent major knee surgeries (except minor arthroscopic), serious coagulation issues, kidney problems or other types of arthritis are excluded.Check my eligibility
What is being tested?
The trial tests the safety of genicular artery embolization (GAE) using HydroPearl® Microspheres in patients with osteoarthritic knee pain. GAE blocks abnormal blood vessels in the knee that contribute to arthritis pain. The study will follow participants for up to 24 months.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may cause discomfort at the injection site, bruising or bleeding complications due to arterial blockage; allergic reactions including anaphylaxis could occur in those sensitive to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or will not undergo surgery for my condition.
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I cannot or will not undergo surgery for my condition.
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I have pain in my knee when touched.
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I am 40 years old or older.
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I have received injections directly into a joint.
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I experience moderate to severe knee pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post gae
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post gae
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with treatment related adverse events
Secondary outcome measures
Mean change from baseline knee function scores
Mean change from baseline pain scores
Trial Design
1Treatment groups
Experimental Treatment
Group I: Genicular artery embolizationExperimental Treatment1 Intervention
Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.
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Who is running the clinical trial?
Andrew PicelLead Sponsor
1 Previous Clinical Trials
Andrew C Picel, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pain hasn't improved after 3 months of treatments like anti-inflammatory meds, physical therapy, or injections.Your MRI shows signs of active joint inflammation.I have rheumatoid or infectious arthritis.I cannot or will not undergo surgery for my condition.You have a blood clotting problem that cannot be fixed.I cannot or will not undergo surgery for my condition.You have mild to moderate joint disease shown on X-rays.You are expected to live for less than 6 months.I have pain in my knee when touched.My kidney function is low (creatinine >2 mg/dL).You are not receiving physical therapy as part of your current treatment plan.I have an infection in my knee.I am 40 years old or older.I have received injections directly into a joint.I am taking anti-inflammatory medications.Your MRI shows signs of active swelling in the joints.Severe blockages in the arteries of the legs that could make specific X-ray tests difficult.I experience moderate to severe knee pain.I have had knee surgery, but not for arthroscopy or meniscus issues.You are allergic to iodine and have had a severe allergic reaction.
Research Study Groups:
This trial has the following groups:- Group 1: Genicular artery embolization
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: NCT04472091 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still underway for this research endeavor?
"According to information hosted on clinicaltrials.gov, this research initiative is still open for enrolment into the trial. The study was initially posted in December 1st 2022 and has been modified most recently on October 25th of the same year."
Answered by AI
How many volunteers are participating in this trial?
"Affirmative. According to clinicaltrials.gov, the trial which was initially publicized in December 1st 2022 is actively seeking participants with 30 patients needed from a single site."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I had ACL reconstruction surgery in 2015 and meniscus repair on the same knee in 2020. Since the second surgery I have struggled to control swelling. Any time I attempt any physical activity beyond walking my knee sweeps up. I have learned to love with it because I would rather be active, but I am desperate for a long term solution.
PatientReceived 2+ prior treatments
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