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Embolization Agent

Embolization with Embosphere Microspheres for Knee Osteoarthritis Pain

N/A

Recruiting

Research Sponsored by Shivank Bhatia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

WOMAC score >30

Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of: Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks (post embolization surgery)

Awards & highlights

Study Summary

This trial will test a permanent embolic for treating knee osteoarthritis by blockage of the geniculate artery.

Who is the study for?

This trial is for adults aged 40-80 with moderate to severe knee osteoarthritis who haven't improved after at least 12 weeks of standard treatments like NSAIDs, steroid injections, or physical therapy. Participants must have synovitis, be able to undergo an MRI, and not have advanced arthritis (Kellgren-Lawrence grade >3), prior knee replacement, certain health conditions that affect embolization procedures, allergies to contrast agents without prophylaxis options, active cancers (except skin cancer), local infections in the knee area or a sensitivity to gelatin.Check my eligibility

What is being tested?

The study tests Embosphere Microspheres used in geniculate artery embolization as a treatment for pain from moderate to severe knee osteoarthritis. The goal is to see how effective and safe this permanent blockage procedure is compared to other treatments.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions due to materials used during the procedure such as iodinated contrast agents or gelatin products within the microspheres. There might also be risks associated with catheter-based interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee or hip pain is severe, based on a score above 30.

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I have tried treatments like painkillers, injections, or physical therapy for my knee arthritis for at least 12 weeks without improvement.

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I have pain in the front area of my knee.

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I am between 40 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks (post embolization surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks (post embolization surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks (post embolization surgery) for reporting.

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 as assessed by the WOMAC

Incidence of treatment related adverse events

Secondary outcome measures

Change in knee pain

Change in knee pain as assessed by VAS

Incidence of adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Embosphere Microspheres groupExperimental Treatment1 Intervention

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Shivank BhatiaLead Sponsor

1 Previous Clinical Trials

4 Total Patients Enrolled

Media Library

Embosphere Microspheres (Embolization Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05112926 — N/A

Osteoarthritis Research Study Groups: Embosphere Microspheres group

Osteoarthritis Clinical Trial 2023: Embosphere Microspheres Highlights & Side Effects. Trial Name: NCT05112926 — N/A

Embosphere Microspheres (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112926 — N/A

Frequently Asked Questions

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

Who is eligible to lend their assistance with this trial?

"To be eligible for this medical research, patients should have knee discomfort and fall within the 40-80 year old age range. The trial has 16 spots open to participants."

Answered by AI

Is this research endeavor enlisting participants at the present time?

"Affirmative. Clinicaltrials.gov shows that this experiment, which was first listed on May 24th 2023, is still recruiting subjects. Approximately 16 patients need to be sourced from 1 medical facility."

Answered by AI

What is the objective of this exploration?

"The principal aim of this trial, assessed over baseline and 24 week intervals post-surgery embolization, is to calculate the incidences of treatment related adverse events. Other metrics include incidence of procedure and osteoarthritis-related adverse effects (as judged by a treating physician), changes in knee pain as calculated through Visual Analog Scale scoring from 0-10 -- with 10 representing greater intensity -- and Whole Organ Magnetic Resonance Imaging Score for assessing synovitis which ranges from 0: no problems; up to 332: severe distress."

Answered by AI

How many participants are currently undergoing treatment within this trial?

"Affirmative. According to the clinicaltrials.gov page, this trial is currently enrolling participants who initially posted on May 24th 2023 and last updated October 27th 2022. There are 16 places available at one particular medical facility."

Answered by AI