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

Study acronym: EMBARDI
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Primary and study completion dates: Apr 15, 2028 to Jul 15, 2028
    • Start date changed from estimate of Dec 15, 2024 to Jan 30, 2025
    • Site contact updated
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 15, 2024 to Dec 15, 2024
    • Site details revised
    v3
  4. Start date: Oct 15, 2024 to Nov 15, 2024
    • Interventions: Embolization therapeutic (Drug) to embolization therapy (Drug)
    • Secondary endpoints: details revised at 1 of 34 entries
    • Study title shortened, about 6 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06611007
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)		 Osteoarthritis
Related terms Osteoarthritis
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov