NCT07477860

Achilles Tendinopathy Embolization

Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Joint & Vascular Institute · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn determine the feasibility of arterial embolization using Lipiodol emulsion to safely and effectively treat chronic Achilles tendon pain due to Achilles tendinopathy in adults aged 25 to 80. The main questions it aims to answer are: 1. Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months? 2. How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device? Participants will: * Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels supplying the Achilles tendon. * Receive a phone call one day after the procedure to check for early side effects. * Participate in four follow-up visits over the course of one year (at 1, 3, 6, and 12 months). Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.

Conditions

• Achilles Tendinopathy (AT)

Interventions

Type	Name	Description
DEVICE	LipioJoint	Participants will receive a transcatheter arterial embolization of the arterial branches supplying the Achilles tendon. The intervention involves selective catheterization of the peritendinous branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic Achilles tendinopathy to alleviate pain and reduce inflammation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study