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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:
Participants will:
Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Achilles Tendonopathy Embolization | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Change | Pain - measured via visual analogue scale at baseline, 1-month, 3-month, 6-month, and 12-month follow-up | Baseline to 12 months |
| Safety (rate of adverse events) | Safety - Percentage of subjects without serious adverse events related to the medical device | Baseline to 12 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Layth Alkhani | Contact | 847-584-3959 | lalkhani@jointvascular.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint and Vascular Institute | Recruiting | Libertyville | Illinois | 60048 | United States |
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