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Taking peoplePhase 1/2

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

Key facts

Who runs it
University Hospital, Grenoble
Where
France1 site in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 1/2
People taking part
15 people, planned
Started
30 Jan 2025
Expected to end
15 Jul 2028
Type of study
Interventional
Treatments tested
  • embolization therapy
Record updated
5 May 2026

Who can take part

Age
40 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Previous thrombosis/dissection of the radial artery
  • History of allergy to iodinated contrast media, LipiodolⓇ or poppies
  • Vasomotor disorders (Raynaud\'s syndrome, scleroderma, acrocyanosis)
  • 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
  • Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.)
  • Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completely resolved within 3 months of the start of the lesion) requiring embolisation
  • Stenosis (\>50%) or known atheromatous arterial occlusion of the upper limbs
  • Known hyperthyroidism or large multinodular goiter
  • 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 interventional clinical trial

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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

The group in the trial

  • Arterial embolization of the hand with LipiodolTreatment being tested

    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.

    Treatment: embolization therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
Record updated
5 May 2026