Artery Embolization for Tennis Elbow
Recruiting in Palo Alto (17 mi)
SP
Overseen bySiddharth Padia, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Siddharth Padia, MD
Disqualifiers: Mild elbow pain, Chronic renal insufficiency, Allergy to iodinated contrast, Active infection, Prior elbow surgery, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
What data supports the effectiveness of the treatment for tennis elbow?
How is the treatment for tennis elbow using Embozene particles different from other treatments?
Research Team
SP
Siddharth Padia, M.D.
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
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 3 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
Trial Timeline
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
Treatment Details
Interventions
- Embozene particles (Embolization Agent)
Trial OverviewThe 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.
Participant Groups
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 Japan for the following indications:
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+
Findings from Research
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]
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]
References
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]