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Embolization Agent
Arterial Embolization for Osteoarthritis
N/A
Recruiting
Led By Bedros Taslakian, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Knee pain resistant to conservative treatment for at least 3 months (anti-inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra-articular injection of hyaluronic acid and/or steroids)
Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 month and 12 month follow up visits
Awards & highlights
Study Summary
This trial is designed to see if a new treatment for OA is safe and works. People with OA will have a procedure to block blood flow to the knee, and then be followed for 12 months.
Who is the study for?
This trial is for adults aged 30-80 with knee pain from osteoarthritis that hasn't improved after trying things like anti-inflammatory drugs, physical therapy, or injections for at least 3 months. They should have a certain level of pain and no major knee surgeries recently. People over 200 Kg, pregnant women, those with serious health issues like cancer or bad kidney function can't join.Check my eligibility
What is being tested?
The study tests if blocking blood flow to the knee using Embozene™ Microspheres through an artery can help with osteoarthritis pain. It's a single-group trial without a placebo where patients are monitored for one year to see how safe and effective this treatment is.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort at the injection site, allergic reaction to materials used during embolization (like contrast dye), temporary numbness or tingling due to nerve irritation, and bruising.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain hasn't improved after 3 months of standard treatments.
Select...
My knee X-ray shows moderate to severe arthritis without bone deformity.
Select...
My knee pain is moderate to severe, scoring 40 or more on a pain scale.
Select...
I can understand and complete English questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 month and 12 month follow up visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 month and 12 month follow up visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score
Secondary outcome measures
Change in Knee Stiffness
Change in Knee pain using the Visual Analogue Scale (VAS) scale
Change in Physical Functioning
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Embolization GroupExperimental Treatment2 Interventions
23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcatheter arterial embolization
2005
N/A
~230
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,676 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,075 Patients Enrolled for Osteoarthritis
Bedros Taslakian, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
40 Total Patients Enrolled
Bedros TaslakianPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee pain hasn't improved after 3 months of treatments like painkillers, physical therapy, or injections.My knee injury happened within the last year or involved a fracture.I currently have a knee infection.I currently have cancer.I have severe artery blockage that affects blood tests or causes leg pain.My knee pain hasn't improved after 3 months of standard treatments.My kidney function is impaired, with creatinine >1.6 or eGFR <60.I have avascular necrosis in my knee.I cannot have an MRI due to claustrophobia, metal in my body, or a pacemaker.I am between 30 and 80 years old.I have had knee surgery on the same side within the last 3 years, or knee replacement at any time.My knee X-ray shows moderate to severe arthritis without bone deformity.My knee pain is moderate to severe, scoring 40 or more on a pain scale.I have had a knee injection in the last 3 months.I have a condition like rheumatoid arthritis, gout, or lupus.I can understand and complete English questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: Embolization Group
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: NCT04379700 — 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 being recruited for this research project?
"Affirmative, the clinicaltrial.gov records indicate that this trial is actively searching for participants. Initially posted on December 1st 2020, it was last modified on November 25th 2022 and seeks 29 patients from one medical facility."
Answered by AI
Are there any opportunities for new participants to join this clinical trial?
"Affirmative. The clinicaltrials.gov website demonstrates that this trial is still open for recruitment, having been posted on December 1st 2020 and last modified November 25th 2022. 29 subjects are needed at a single research site."
Answered by AI
Is this particular experiment open to patients aged 55 and older?
"Consistent with the guidelines of this medical trial, prospective patients must be between 30 and 80 years old to qualify for involvement."
Answered by AI
How can I contribute to this medical experiment?
"This clinical experiment is seeking 29 people afflicted with arthrosis, of any gender, between the ages of 30 and 80. The Kellgren-Lawrence Grade must be 2, 3 or 4 (if there are no bony deformities). Participants should have experienced knee pain for a minimum of three months which has been resistant to conventional treatments such as anti-inflammatory drugs and physical therapy .The severity of discomfort needs to be moderate to severe as determined by a visual analogue scale score greater than 40 out 0f 100. Lastly, all candidates need to display mental competency in order to provide informed consent while being able complete study questionnaires written"
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
To see if I can help other with this pain in the future. I have gone through approximately 10 years plus worth of osteoarthritis knees, and need some viable alternatives to my increasingly difficult pain.
PatientReceived 1 prior treatment
I have had worsening knee pain for since 2014 and the last year has been worse than ever before I used to get released during the summer now I don’t if I use my knee while today my walking too much I will most likely get something at night time, it’s been very difficult finding any relief….
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How how long does this study last and does it contain any monetary compensation? I would also like to know if the treatment works for me will I be able to continue using this new treatment?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- NYU Langone Health: < 48 hours
Average response time
- < 2 Days
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