Achilles Tendinopathy (AT)Phase 1NCT07477860
Achilles Tendinopathy Embolization
A Phase 1 study testing LipioJoint in people with Achilles Tendinopathy (AT), run by Joint & Vascular Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Achilles Tendinopathy (AT)
- What is being tested?
- LipioJoint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joint and Vascular Institute
Libertyville, Illinois, 60048
Layth Alkhani, 847-584-3959, lalkhani@jointvascular.com
About this study
Official title: Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
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:
- Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months?
- How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?
Read more
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)
- Being tested
- LipioJoint
- Keywords
- achilles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipioJointDevice
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 group | Role | What they receive |
|---|---|---|
| Experimental: Achilles Tendonopathy Embolization | Experimental | Not described Receives: Device: LipioJoint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change
Pain - measured via visual analogue scale at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Measured: Baseline to 12 months
Safety (rate of adverse events)
Safety - Percentage of subjects without serious adverse events related to the medical device
Measured: Baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendinopathy (AT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint & Vascular Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477860
- Sponsor's protocol ID
- G260029
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT07477860
- Acronym / sponsor ID
- G260029
- Conditions
- Achilles Tendinopathy (AT)
- Keywords
- achilles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Joint & Vascular InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months?
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Achilles Tendonopathy Embolization | Experimental | Device: LipioJoint |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipioJointParticipants 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. | Device | Experimental: Achilles Tendonopathy Embolization |
Primary outcome
Pain Change
Time frame: Baseline to 12 months
Pain - measured via visual analogue scale at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Safety (rate of adverse events)
Time frame: Baseline to 12 month follow-up
Safety - Percentage of subjects without serious adverse events related to the medical device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LipioJoint in people with Achilles Tendinopathy (AT), run by Joint & Vascular Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layth Alkhani (847-584-3959, lalkhani@jointvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.