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Embolization Agent
Artery Embolization for Tennis Elbow
N/A
Recruiting
Led By siddharth padia, M.D.
Research Sponsored by Siddharth Padia, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of lateral epicondylitis based on history and physical exam
Age ≥ 18 years and less than 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial looks at whether blocking blood flow to the elbow can help reduce pain from tennis elbow.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, allergic reactions to materials used (if allergy management fails), complications from reduced blood flow such as tissue damage around the treated area, and general risks associated with embolization procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with tennis elbow.
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I am between 18 and 79 years old.
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I have moderate to severe elbow pain during physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hand
Secondary outcome measures
Change in imaging
Change in symptoms as assessed by the QuickDASH scores.
Change in symptoms as assessed by the patient-rates tennis elbow evaluation (PRTEE) scores.
+1 moreTrial Design
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.
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Who is running the clinical trial?
Siddharth Padia, MDLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
siddharth padia, M.D.Principal InvestigatorUniversity of California, Los Angeles
Siddharth Padia, M.D.Principal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is low (creatinine >2 mg/dL).My condition did not improve after 6 months of standard treatments like painkillers, physical therapy, or steroid injections.I do not have an active infection or another type of cancer.My elbow pain is mild.I have had surgery on my elbow before.I am allergic to iodine-based dyes and steroids don't help.I have been diagnosed with tennis elbow.I have a bleeding disorder that cannot be corrected.I am between 18 and 79 years old.I have moderate to severe elbow pain during physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Elbow Artery Embolization (EAE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the participant eligibility for this research study extended to individuals over 25 years old?
"This trial is seeking individuals over 18 years of age and below the age of 80."
Answered by AI
Are there any vacancies remaining for potential participants in this study?
"Based on the information available through clinicaltrials.gov, this research initiative is presently seeking participants. The initial posting of the trial was dated March 21st 2023, with subsequent updates occurring at that same date."
Answered by AI
To what population is this clinical trial open?
"Patients that wish to be part of this research must have tennis elbow and lie within the range of 18-80 years old. Currently, 25 individuals are being recruited for the clinical trial."
Answered by AI
How many participants are being recruited for this research endeavor?
"Affirmative. According to the details available on clinicaltrials.gov, this healthcare trial has been recruiting since March 21st 2023 and is currently searching for 25 participants from one medical centre."
Answered by AI
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