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NCT04682652 · ClinicalTrials.gov registry record · NA

Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis

A NA study of Knee Osteoarthritis and Degenerative Joint Disease of Knee, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT04682652: Recruiting NA study of Knee Osteoarthritis and Degenerative Joint Disease of Knee, sponsored by University of California, Los Angeles.

NCT04682652 is a NA study of Knee Osteoarthritis and Degenerative Joint Disease of Knee that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 100 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04682652, a NA study of Knee Osteoarthritis and Degenerative Joint Disease of Knee, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going to the specific area of pain. If the investigator can reduce the blood flow, the inflammation can be reduced and the pain can be controlled. The GAE procedure is an experimental procedure to decrease the blood flow (embolize) to the specific region of the knee that is causing the pain. This will be done by infusing microscopic spheres into the specific blood vessel (genicular artery) supplying the area of pain in the knee. This is done through a procedure which is called an angiogram, which is done entirely through a pinhole at the creased of the thigh, using twilight (conscious) sedation. The investigators have already completed an initial trial at UCLA, and shown that this procedure is safe and effective. The purpose of this new trial is to compare outcomes of people undergoing the GAE procedure to those who do not undergo the procedure. A total of 100 patients will be enrolled, and 2/3 of the patients will be randomly selected to undergo the GAE procedure. 1/3 will not undergo the procedure. This is known as a randomized trial. During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Primary Outcome

The primary evaluation is the change in clinical response, measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The primary endpoint is percentage of subjects achieving at least a 50% reduction in WOMAC at 6 months with an intent-to-treat analysis.

Interventions

  • DEVICE Embozene MicroSpheres

Study Locations (1)

California

  • UCLA Santa Monica Hospital - Santa Monica

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-08-01
Est. Completion 2027-10-01
Phase NA

What NCT04682652 shows while recruiting

NCT04682652 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (67% lower).

The record links to 2 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Embozene MicroSpheres is the first listed.

NCT04682652 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04682652 about?

NCT04682652 is a clinical study titled "Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis". The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going...

What is the current status of trial NCT04682652?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-08-01. Estimated completion is 2027-10-01.

What conditions does trial NCT04682652 study?

This clinical trial studies the following conditions: Knee Osteoarthritis, Degenerative Joint Disease of Knee.

What interventions are being tested in trial NCT04682652?

The interventions under investigation include: Embozene MicroSpheres (DEVICE).

Who is sponsoring clinical trial NCT04682652?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04682652 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Knee Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04682652's enrollment target sits among peer trials

100 42nd of 101 higher than 56 of 101 other Knee Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04682652, the US trial registry maintained by the National Library of Medicine. NCT04682652 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.