drugset / Trial / NCT06497140

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

NCT06497140

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-09-30
Primary completion
2028-01-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject lipiodol Unknown Other

Indications