Actively Recruiting
Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
Led by Joint & Vascular Institute · Updated on 2026-04-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of using arterial embolization with a Lipiodol emulsion to treat chronic pain caused by Achilles tendinopathy in adults between 25 and 80 years old. This early phase 1 study aims to determine if the procedure can safely and effectively reduce pain levels over a 12-month period, while monitoring for any serious medical problems or adverse events related to the device. Participants will undergo a minimally invasive procedure where a doctor inserts a small tube (catheter) to inject LipioJoint, a mixture of Lipiodol and iodinated contrast media, into the blood vessels supplying the Achilles tendon. The injection is performed under fluoroscopic guidance targeting the hypervascularity linked to tendinopathy. Up to 5 mL of Lipiodol will be used per procedure. Afterward, participants receive a follow-up phone call within one day to check for early side effects and attend four in-person visits at 1, 3, 6, and 12 months. Throughout the study, participants will complete pain surveys using the Visual Analog Scale (VAS) and report any changes in other therapies or medications they use. Researchers will assess pain changes from baseline to 12 months and monitor the rate of adverse events during this follow-up. The total participation lasts one year, providing detailed safety and effectiveness data on this embolization procedure for chronic Achilles tendon pain.
CONDITIONS
Brief Title
Achilles Tendinopathy Embolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 25 years
- Provides written informed consent
- Has Achilles tendinopathy not improved after at least 3 months of conservative management
- Reports pain of at least 4 out of 10 on the Visual Analog Scale (VAS)
- Is a non-surgical candidate or wishes to avoid surgery
You will not qualify if you...
- Achilles tendon pain due to acute fracture, recent trauma, inflammatory conditions, muscle or ligament injury, tendon rupture, or bone mineral density issues
- Received steroid injection within 90 days prior to the procedure
- Known severe allergy to Lipiodol or iodinated contrast media
- Diagnosed peripheral arterial disease affecting the lower limbs
- Pregnant or breastfeeding
- Has anticoagulation or irreversible blood clotting problems
- Has kidney problems with GFR less than 45 or serum creatinine over 2.0 mg/dl
- Has type 1 diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure
Participants undergo a transcatheter arterial embolization procedure targeting the arterial branches supplying the Achilles tendon to reduce pain and inflammation associated with Achilles tendinopathy.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and pain changes after the embolization procedure.
Scheduled follow-up visits during 12 months
Trial Site Locations
Total: 1 location
1
Joint and Vascular Institute
Libertyville, Illinois, United States, 60048
Actively Recruiting
Research Team
L
Layth Alkhani
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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