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RECRUITING
NCT06497140
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-09-30

Completion Date

2028-10-01

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DRUG

Ethiodized Oil-based emulsion

Embolization of genicular arteries

PROCEDURE

Sham-operation

Mimicked catheterization and embolization of genicular arteries

Locations (3)

Hôpital Saint Antoine - APHP

Paris, France

Hôpital Cochin - APHP

Paris, France

Hôpital européen Georges Pomidou - APHP

Paris, France