Clinical Trial

Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2

Study acronym: LIPIOJOINT-2
Recruiting Phase 3
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Summary
Knee OsteoArthritis (KOA) is a common disease associated with pain and impaired function. Many patients are not relieved of their symptoms with enough efficacy by conservative treatments. Genicular Arteries Embolization (GAE) is a new minimally invasive endovascular treatment allowing symptoms relief. The investigator previously demonstrated the safety of GAE using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a first-in-man single-arm clinical trial called LipioJoint-1 (clinicaltrials.gov: NCT04733092; EUDRACT: 2020-002206-10). This phase 1 study also provided encouraging evidence of GAE efficacy on knee pain and function. The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter, prospective, randomized sham-controlled clinical trial.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-04; most recent amendment 2024-10-11.
Status change: Not Yet Recruiting → Recruiting 2024-10-11
Trial Details
NCT Number NCT06497140
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Ministry of Health, France
Conditions Knee Osteoarthritis
Enrollment 130 participants
Start Date 2024-09-30
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-15