Artery Embolization for Tennis Elbow

Overseen By Aniket Joglekar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Siddharth Padia, MD

Disqualifiers: Mild elbow pain, Chronic renal insufficiency, Allergy to iodinated contrast, Active infection, Prior elbow surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 day

25 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

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.

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?

Group I: Elbow Artery Embolization (EAE) Experimental Treatment 1 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transcatheter arterial embolization (TAE) resulted in a necrosis rate of over 95% in 35 small hepatocellular carcinoma (S-HCC) tumors, indicating its high efficacy in treating smaller tumors, while larger tumors (L-HCC) showed lower necrosis rates.

The presence of a thickened tumor capsule post-TAE serves as a reliable indicator of treatment response, and the proliferative activity measured by PCNA can help assess the viability of residual tumors, particularly in distinguishing between tumor and non-tumor areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocellular carcinoma after transcatheter hepatic arterial embolization. A histopathologic study of 84 resected cases. Higuchi, T., Kikuchi, M., Okazaki, M.[2022]

The modified CalliSpheres® bead (CB/Lid-10) effectively combines an embolic agent with lidocaine to reduce pain during transcatheter arterial embolization (TAE) for advanced hepatocellular cancer, demonstrating good biocompatibility and sustained drug release.

CB/Lid-10 not only alleviates post-operative pain by improving the inflammatory environment but also selectively targets and kills tumor cells by blocking their blood supply and promoting apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-step fabrication of lidocaine/CalliSpheres® composites for painless transcatheter arterial embolization. Tian, C., Wang, Z., Huang, L., et al.[2022]

Transarterial embolization (TAE) effectively induces tumor necrosis in patients with advanced hepatocellular carcinoma (HCC), allowing some patients to meet the Milan criteria for liver transplantation after treatment.

In a study of 12 cirrhotic patients, TAE resulted in high survival rates of 92% at 1 year and 73% at 2 years post-transplant, demonstrating its potential to improve outcomes for patients awaiting liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The significance of transarterial embolization for advanced hepatocellular carcinoma in liver transplantation. Sun, PL., Chen, CL., Hsu, SL., et al.[2004]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Short-term Results of Transcatheter Arterial Embolization for Chronic Medial Epicondylitis Refractory to Conservative Treatment: A Single-Center Retrospective Cohort Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Early Results of Transcatheter Arterial Embolization for Relief of Chronic Shoulder or Elbow Pain Associated with Tendinopathy Refractory to Conservative Treatment. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Hepatocellular carcinoma after transcatheter hepatic arterial embolization. A histopathologic study of 84 resected cases. [2022]

5. England pubmed.ncbi.nlm.nih.gov

One-step fabrication of lidocaine/CalliSpheres® composites for painless transcatheter arterial embolization. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The significance of transarterial embolization for advanced hepatocellular carcinoma in liver transplantation. [2004]