Achilles Tendinopathy Embolization

Conditions

• Achilles Tendinopathy (AT)

Eligibility Criteria

Sex

ALL

Age

25 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LipioJoint — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Experimental: Achilles Tendonopathy Embolization

Primary Outcome Measure

Pain Change [ Time Frame: Baseline to 12 months ]

Central Contacts

• Layth Alkhani
  847-584-3959
  [email protected]

Locations (1)

Find similar trials in Libertyville, IL

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