Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-05-03 @ 2:59 PM
Study NCT ID:
NCT07477860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Achilles Tendinopathy Embolization
Sponsor:
Joint & Vascular Institute
Organization:
Study Overview
Official Title:
Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: