25 Participants Needed

Artery Embolization for Tennis Elbow

SC
AA
CB
PJ
SA
AJ
Overseen ByAniket Joglekar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment for tennis elbow that aims to reduce pain. It targets patients who haven't responded to other treatments. The goal is to see if this method is safe and effective.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves a procedure rather than medication, you might not need to stop them. It's best to discuss this with the trial coordinators.

How is the treatment for tennis elbow using Embozene particles different from other treatments?

The treatment using Embozene particles for tennis elbow is unique because it involves transcatheter arterial embolization (TAE), a procedure that blocks abnormal blood vessels to reduce pain and inflammation, unlike traditional treatments that may focus on physical therapy or medication.12345

What data supports the effectiveness of the treatment for tennis elbow?

Research shows that transcatheter arterial embolization (TAE) has been effective in reducing pain for conditions similar to tennis elbow, such as chronic medial and lateral epicondylitis, which are types of elbow pain that don't improve with other treatments.12346

Who Is on the Research Team?

SP

Siddharth Padia, M.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with moderate to severe tennis elbow pain that hasn't improved after at least 6 months of treatments like NSAIDs, physical therapy, or steroid injections. Participants must be able to consent and have a life expectancy over a year. It's not for those with chronic kidney issues, contrast agent allergies unmanageable by steroids, bleeding problems, mild pain, infections/malignancy in the elbow area or previous surgery on the affected elbow.

Inclusion Criteria

My condition did not improve after 6 months of standard treatments like painkillers, physical therapy, or steroid injections.
Life expectancy greater than 12 months
I have been diagnosed with tennis elbow.
See 2 more

Exclusion Criteria

My kidney function is low (creatinine >2 mg/dL).
I do not have an active infection or another type of cancer.
My elbow pain is mild.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo elbow artery embolization (EAE) with Embozene microspheres

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
6 visits (in-person) at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Embozene particles
Trial Overview The study tests if blocking blood flow to painful areas of the elbow using Embozene particles can safely and effectively treat tennis elbow. This procedure involves injecting these tiny spheres into an artery leading to the painful region in order to reduce blood supply and alleviate pain.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Elbow Artery Embolization (EAE)Experimental Treatment1 Intervention
Patients will undergo EAE with Embozene microspheres (75 micron). The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the patient's pain.

Embozene particles is already approved in United States, Japan for the following indications:

🇺🇸
Approved in United States as Embozene for:
  • Hypervascular tumors
  • Arteriovenous malformations
  • Investigational use for lateral epicondylitis (tennis elbow)
🇯🇵
Approved in Japan as Transcatheter Arterial Embolization (TAE) for:
  • Lateral epicondylitis (tennis elbow)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Siddharth Padia, MD

Lead Sponsor

Trials
2
Recruited
70+

Published Research Related to This Trial

Transcatheter arterial embolization (TAE) was found to be effective in treating chronic medial epicondylitis (ME) in 10 patients, achieving clinical success in 85.7% of procedures, with significant pain relief and functional improvement over a 6-month follow-up period.
No major complications were reported, indicating that TAE is a safe option for patients with ME who have not responded to conservative treatments.
Short-term Results of Transcatheter Arterial Embolization for Chronic Medial Epicondylitis Refractory to Conservative Treatment: A Single-Center Retrospective Cohort Study.Lee, JH., Kim, DH., Lee, SH., et al.[2022]
Transcatheter arterial embolization (TAE) was found to be a safe and effective treatment for 22 patients with lateral epicondylitis who had not responded to conservative treatments for over 3 months, showing significant improvements in pain and function over a 2-year follow-up period.
All patients experienced a reduction in pain and improvement in arm function, with no major adverse events reported, indicating that TAE could be a viable option for those suffering from this condition.
Transcatheter arterial embolization of abnormal vessels as a treatment for lateral epicondylitis refractory to conservative treatment: a pilot study with a 2-year follow-up.Iwamoto, W., Okuno, Y., Matsumura, N., et al.[2018]
Transcatheter arterial embolization was found to be effective in relieving chronic shoulder and elbow pain in 73% of the 15 cases studied, with significant pain reduction observed over four months, particularly in patients showing evident angiographic enhancement.
The study suggests that the degree of angiographic enhancement after embolization may influence the level of pain relief, indicating that this could be an important factor in treatment outcomes.
Early Results of Transcatheter Arterial Embolization for Relief of Chronic Shoulder or Elbow Pain Associated with Tendinopathy Refractory to Conservative Treatment.Hwang, JH., Park, SW., Kim, KH., et al.[2018]

Citations

Short-term Results of Transcatheter Arterial Embolization for Chronic Medial Epicondylitis Refractory to Conservative Treatment: A Single-Center Retrospective Cohort Study. [2022]
Transcatheter arterial embolization of abnormal vessels as a treatment for lateral epicondylitis refractory to conservative treatment: a pilot study with a 2-year follow-up. [2018]
Early Results of Transcatheter Arterial Embolization for Relief of Chronic Shoulder or Elbow Pain Associated with Tendinopathy Refractory to Conservative Treatment. [2018]
Hepatocellular carcinoma after transcatheter hepatic arterial embolization. A histopathologic study of 84 resected cases. [2022]
One-step fabrication of lidocaine/CalliSpheres® composites for painless transcatheter arterial embolization. [2022]
The significance of transarterial embolization for advanced hepatocellular carcinoma in liver transplantation. [2004]
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