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 explores a new procedure to help people with tennis elbow, a condition causing pain on the outer part of the elbow. The treatment uses tiny spheres called Embozene particles to block blood flow to the painful area, potentially reducing pain. The study aims to determine if this method is both safe and effective. Individuals with tennis elbow pain that hasn't improved with standard treatments for at least six months might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

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.

What prior data suggests that this embolization procedure is safe for treating tennis elbow?

Research has shown that Embozene particles, used in treating tennis elbow, have a strong safety record. The FDA has already approved these particles for other uses, such as treating certain tumors and abnormal blood vessels. Studies have found them generally safe for these purposes.

Evidence also indicates that transcatheter arterial embolization, a method that blocks blood supply, is safe for treating various painful conditions, including tennis elbow. This suggests that using Embozene particles for tennis elbow might also be safe. Current studies have not identified any major safety concerns, making this treatment promising for those seeking relief from elbow pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for tennis elbow, like physical therapy, anti-inflammatory medications, or even surgery, focus on relieving symptoms or repairing damaged tissues. But the elbow artery embolization (EAE) technique is different because it uses Embozene microspheres to directly target the blood supply to the painful areas, potentially reducing inflammation and pain more effectively. This minimally invasive procedure offers a novel approach by cutting off tiny arteries to decrease blood flow, which may lead to faster pain relief and recovery compared to existing methods. Researchers are excited because it could provide a new option for patients who haven't found relief with traditional treatments.

What evidence suggests that this embolization treatment is effective for tennis elbow?

Research has shown that using Embozene particles to block blood flow in the elbow can help reduce pain from tennis elbow. In this trial, participants will undergo Elbow Artery Embolization (EAE) with Embozene microspheres. Studies have found that stopping blood flow to the painful area can decrease the growth of blood vessels, potentially leading to less pain. In one study, patients who received similar treatments reported significant pain relief. Embozene particles are already approved for other uses, such as treating certain tumors and blood vessel problems, and have been shown to be safe. While more research is needed specifically for tennis elbow, these early results are promising. ^{1 2 3 6 7}

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05325242

NCT05325242 | Elbow Artery Embolization for Tennis Elbow Embozene particles are FDA approved for the embolization of hypervascular tumors and arteriovenous malformations. Several studies have shown excellent safety ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1089251622000877

Elbow Artery Embolization for Lateral Epicondylitis Embolization of the arteries supplying the elbow decreases the neo-vascularity seen in epicondylitis. The procedure may result in marked improvement in pain ...

3. clinicaltrial.be clinicaltrial.be/en/details/262543?per_page=100&only_recruiting=0&only_eligible=0

Elbow Artery Embolization for Tennis Elbow - Clinical Tri... Embozene particles are FDA approved for the embolization of hypervascular tumors and arteriovenous malformations. Several studies have shown ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9818587/

Transcatheter Arterial Embolization for Alleviating Chronic ... A cohort study evaluated the efficacy of TAE in 13 patients with shoulder or elbow tendinopathy, including calcific tendinitis, rotator-cuff ...

5. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/full/10.1002/acr2.11383

Transarterial Embolization for the Treatment of Chronic ... Midterm clinical outcomes after transcatheter arterial embolization for lateral epicondylitis resistance to conservative treatment [abstract].

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28734535/

Transcatheter arterial embolization of abnormal vessels as ... The purpose of this study was to describe the safety and efficacy of transcatheter arterial embolization (TAE) for lateral epicondylitis resistant to ...

7. researchgate.net researchgate.net/publication/318551262_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

Transcatheter arterial embolization of abnormal vessels as ... The purpose of this study was to describe the safety and efficacy of transcatheter arterial embolization (TAE) for lateral epicondylitis ...