Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refracto… (NCT06611007) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
France15 participantsStarted 2025-01-30
Plain-language summary
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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged ≥ 40 years.
* Osteoarthritis of the hand according to American College of Rheumatology criteria 1990
* Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥ 2.
* Symptomatic osteoarthritis within the last 3 months.
* Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painful hand).
* Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
* Patient affiliated to french social security or a similar health assurance.
Exclusion Criteria:
* History of allergy to iodinated contrast media, LipiodolⓇ or poppies.
* Vasomotor disorders (Raynaud\'s syndrome, scleroderma, acrocyanosis).
* Stenosis (\>50%) or known atheromatous arterial occlusion of the upper limbs.
* Obliterative arterial disease of the lower limbs at the critical ischaemia stage.
* Severe to end-stage chronic renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m2), dialysis or renal transplant.
* Arteritis such as thromboangiitis obliterans disease or other diseases
* Previous thrombosis/dissection of the radial artery.
* Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.).
* Known hyperthyroidism or large multinodular goiter.
* Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completely resolved within 3 months of the start of the lesion) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
Timeframe: From embolization to 6 months after embolization