Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for… (NCT05112926) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
United States9 participantsStarted 2022-12-08
Plain-language summary
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has signed informed consent
* Subject is age 40-80
* Subject is able to have an MRI
* Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:
a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
* Localized tenderness in anterior knee area
* Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
* Synovitis present as assessed by WORMS
* VAS \>50 mm
* WOMAC score \>30
Exclusion Criteria:
* Rheumatoid arthritis
* Local infection of the target knee(s)
* Kellgren-Lawrence grade \>3
* Osteonecrosis evident by MRI
* Prior knee arthroplasty
* Allergy to iodinated contrast agents that cannot be managed by prophylaxis
* Hypersensitivity to gelatin products
* Any known condition that limits catheter-based intervention or is a contraindication to embolization
* Active malignancy other than non-melanomatous skin cancer
* Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
* Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.