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Tiny spheres aim to ease knee arthritis pain without surgery

NCT ID NCT04682652

Symptom relief Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a procedure called genicular artery embolization (GAE) for knee osteoarthritis pain. It involves injecting microscopic spheres into a knee artery to reduce blood flow and inflammation. About 100 people with moderate to severe knee pain will be randomly assigned to receive GAE or just observation. The goal is to see if GAE provides significant pain relief compared to no treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Embozene MicroSpheres (tiny spheres injected into knee artery to reduce blood flow)
What this could lead to
If it works, this could offer a new, minimally invasive option for knee osteoarthritis pain relief without surgery.
What could go wrong
This is a relatively small, early-stage trial. The procedure is experimental, and results may not apply to all patients. Risks include potential complications from the angiogram and embolization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Subjects must meet all of the following inclusion criteria in order to be eligible for this study: * Provided informed consent * Age ≥ 40 years and less than 80 years * Ineligibility for or refusal of surgical management * Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10 * Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date. * Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/ hyaluronic acid joint injection) for at least 3 months * Able to comply with all treatments and protocol follow-up visits Exclusion Criteria Subjects that meet any of the following exclusion criteria will not be eligible for this study: * Mild knee pain as determined by visual analog scale \< 5 out of 10 * OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation * Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min. * Significant arterial atherosclerosis that would limit selective angiography * History of fibromyalgia, autoimmune, or inflammatory disorder * History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine * Allergy to iodinated contrast agents * Active Infection or malignancy * Recent (within 12 months) or active nicotine use * Prior total or partial knee replacement in the subject knee * Active pregnancy * Uncorrectable bleeding diasthesis * Other medical, social, or psychological/physical conditions that, in the opinion of the investigator, preclude the patient from participating in the study.

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Conditions

The condition(s) this trial relates to.

Chronic Pain osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative joint disease of knee Knee osteoarthritis

Contacts and locations

Locations

  • UCLA Santa Monica Hospital

    Santa Monica, California, 90404, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.