Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment

Sponsor
University Hospital, Grenoble
Study ID
NCT06611007
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • embolization therapy — DRUG
    Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent

Study Details

The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function. The main questions it aims to answer are: * What are the side effects and complications associated with the Lipiodol® arterial embolization procedure? * Does arterial embolization reduce pain intensity and improve hand function? Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will: * Undergo arterial embolization with Lipiodol® * Participate in regular follow-ups to monitor pain relief, hand function, and any side effects * Have imaging studies to assess changes in joint vascularisation and damage

Key Dates

First listed
Sep 24, 2024
Start date
Jan 30, 2025
Status verified
May 2026
Primary completion
Jul 15, 2028
Completion
Jul 15, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arterial embolization of the hand with Lipiodol
    The radial artery will be embolized with Lipiodol emulsified 3:1 with iodinated contrast medium (Optiray 300 mg/ml). The most painful hand according to VAS pain will be treated.

Primary Outcome Measure

Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE [ Time Frame: From embolization to 6 months after embolization ]

Central Contacts

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