- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325242
Elbow Artery Embolization for Tennis Elbow
Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, prospective, single arm investigational study to evaluate the safety of elbow artery embolization (EAE) for treatment of symptomatic lateral epicondylitis. In addition, the improvement as part of efficacy will be reported. All patients will have either failed or be intolerant to conservative management. Patients will be considered enrolled in the study once they have provided informed consent and have been determined to meet all eligibility criteria. A total of 25 patients will be enrolled in the single treatment arm of the study and will be followed for 24 months.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will undergo EAE with Embozene microspheres (75 micron). Following treatment, subjects will return for follow-up visits at 1 week, 1 month (± 2 weeks), 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 4 weeks), and 24 months (± 4 weeks) post-procedure. At these visits, subjects will undergo a directed physical examination, report any new adverse events (AEs), and complete questionnaires. At 12 months of follow-up, subjects will also undergo elbow MRI and x-ray.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Purva Joshi
- Phone Number: 424-402-6599
- Email: PMJoshi@mednet.ucla.edu
Study Contact Backup
- Name: Siddharth A Padia, M.D.
- Phone Number: 310-481-7545
- Email: SPadia@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Aniket Joglekar
- Phone Number: 310-948-8026
- Email: ajoglekar@mednet.ucla.edu
-
Contact:
- Purva Joshi
- Phone Number: 424-402-6599
- Email: PMJoshi@mednet.ucla.edu
-
Principal Investigator:
- Siddarth A Padia, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years and less than 80 years
- Diagnosis of lateral epicondylitis based on history and physical exam
- Ability to provide informed consent
- Life expectancy greater than 12 months
- Moderate-severe lateral elbow pain as determined by visual analog scale > 4 (based on average severity during physical activity)
- Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months.
Exclusion Criteria:
- Mild elbow pain as determined by visual analog scale < 4
- Chronic renal insufficiency (serum creatinine >2 mg/dL)
- Allergy to iodinated contrast agents that is not responsive to steroid management
- Active Infection or malignancy
- Prior elbow surgery in the subject elbow
- Uncorrectable bleeding diathesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elbow Artery Embolization (EAE)
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 are FDA approved for the embolization of hypervascular tumors and arteriovenous malformations.
Several studies have shown excellent safety and efficacy with regards to tumor control and objective response in liver cancer.
It has been used extensively for the treatment of symptomatic uterine fibroids, where Embozene embolization of the uterine arteries results in necrosis of uterine fibroids and cessation of abnormal vaginal bleeding.
Other proven uses include embolization of arteriovenous malformations and fistulas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the efficacy of EAE in treating pain measured as percentage of subjects with a greater than 50% decrease in QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score at 12 months.
Time Frame: 12 months
|
Changes in QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score as a measure of efficacy.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Visual Analog Scan (VAS) as a measure of efficacy
Time Frame: 24 months
|
The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10.
Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10).
Participant is asked to point to the face that shows how much participant hurts at the time of assessment.
|
24 months
|
Change in symptoms as assessed by the QuickDASH scores.
Time Frame: 24 months
|
the QuickDASH (Disabilities of the Arm, Shoulder, and Hand) uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
each item has 5 response options, ranging from 1 (no difficulty) to 5 (unable) and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability)
|
24 months
|
Change in symptoms as assessed by the patient-rates tennis elbow evaluation (PRTEE) scores.
Time Frame: 24 months
|
Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis.
The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10 ("0" being no pain, and "10" being worst imaginable).
|
24 months
|
Change in imaging
Time Frame: 12 months
|
Change in radiographic imaging by elbow MRI and elbow radiograph
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Siddharth Padia, M.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-000161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lateral Epicondylitis, Unspecified Elbow
-
Hospital for Special Surgery, New YorkActive, not recruitingLateral Epicondylitis | Lateral Epicondylitis, Unspecified Elbow | Lateral Epicondylitis, Left Elbow | Lateral Epicondylitis, Right Elbow | Lateral Epicondylitis (Tennis Elbow) Bilateral | Medial Epicondylitis | Medial Epicondylitis, Right Elbow | Medial Epicondylitis, Left ElbowUnited States
-
Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow
-
Uskudar State HospitalRecruitingLateral Epicondylitis | Lateral Epicondylitis, Unspecified ElbowTurkey
-
European University of LefkeCompletedLateral Epicondylitis (Tennis Elbow) Bilateral | Pain in Arm, Unspecified | Tenosynovitis Elbow
-
McMaster UniversityArthrex, Inc.; The Physicians' Services Incorporated Foundation; Radiological...TerminatedLateral Epicondylitis (Tennis Elbow)Canada, United States
-
Haseki Training and Research HospitalCompletedLateral Epicondylitis (Tennis Elbow)Turkey
-
Chuncheon Sacred Heart HospitalRecruitingLateral Epicondylitis of ElbowKorea, Republic of
-
University of CadizNot yet recruitingElbow Tendinopathy | Epicondylitis | Epicondylitis, Lateral | Epicondylitis of the Elbow
-
Mennallah Ahmed Mohamed Anwar ElgendyNot yet recruiting
-
Indiana Hand to Shoulder CenterCTM BiomedicalEnrolling by invitationTennis Elbow | Lateral Elbow Tendinopathy | Lateral Epicondylitis \(Tennis Elbow\)United States
Clinical Trials on Embozene particles
-
University of CalgaryWithdrawn
-
University of MinnesotaWithdrawn
-
Varian, a Siemens Healthineers CompanyRecruitingKnee OsteoarthritisUnited Kingdom
-
Brigham and Women's HospitalGuerbetWithdrawnArterial Occlusion | Knee Pain Chronic | Knee Swelling PainUnited States
-
University of VirginiaSiemens Medical SolutionsUnknownProstatic Hyperplasia | Hyperplasia | Male Urogenital Diseases | Prostatic Hypertrophy | Benign Prostatic Hyperplasia (BPH) | Genital Diseases, Male | Lower Urinary Tract Symptoms (LUTS) | ProstatismUnited States
-
University of North Carolina, Chapel HillCompletedOsteoarthritis Of KneeUnited States
-
Boston Scientific CorporationTerminated
-
NYU Langone HealthRecruiting
-
Jena University HospitalBoston Scientific CorporationCompletedBenign Prostatic HyperplasiaGermany
-
Hadassah Medical OrganizationCompleted