Early Feasibility Study of Achilles Tendinopathy Treatment Using LipioJoint Arterial Embolization in Adults Aged 25 to 80

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.

Achilles Tendinopathy Embolization