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Tests treatment safety and results for Osteoarthritis
Official title Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
ClinicalTrials.gov ID: NCT06611007
What this study is testing
What is embolization therapy?
embolization therapy is an investigational medicine, being studied as a potential treatment for osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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.
- 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) requiring embolisation.
- Pregnant or breast-feeding.
- Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code and/or who do not speak French.
- Patients in a period of exclusion or in the course of another treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Échirolles, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Échirolles, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.