Recruiting
Phase 1

Lipiodol Emulsion

Sponsor:

Joint & Vascular Institute

Code:

NCT07477860

Conditions

Achilles Tendinopathy (AT)

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

LipioJoint

Study Details

Brief 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)

Study ID

NCT07477860

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 25 years
  • Subject provides written informed consent
  • Patient with Achilles tendinopathy refractory to 3 months of conservative management
  • Self reported pain of at least 4/10 on visual analog scale (VAS)
  • Non-surgical candidate/looking to avoid surgery

Exclusion Criteria:

  • Achilles tendon pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, tendon rupture, and etiologies related to bone mineral density
  • Steroid injection in the last 90 days from the embolization procedure
  • Known severe allergy to Lipiodol and/or iodinated contrast media
  • Diagnosis of peripheral arterial disease affecting the lower extremities
  • Pregnancy or breastfeeding
  • Anticoagulation or irreversible coagulopathy
  • GFR <45 or Serum creatinine > 2.0 mg/dl
  • Type 1 Diabetes Mellitus

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Experimental: Achilles Tendonopathy Embolization

Interventions

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.

Primary outcome measure

  • Pain Change [ Time Frame: Baseline to 12 months ]
  • Safety (rate of adverse events) [ Time Frame: Baseline to 12 month follow-up ]

Central Contacts and Locations

Central contacts

Layth Alkhani

847-584-3959lalkhani@jointvascular.com

Locations

Joint and Vascular Institute

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Layth Alkhani

847-584-3959lalkhani@jointvascular.com

More Information

Sponsor

Joint & Vascular Institute

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • achilles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joint & Vascular Institute on 2026-04-23.