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NCT05423587 · ClinicalTrials.gov record · last posted 2024-12-03

Genicular Artery Embolisation for Knee Osteoarthritis II

Study acronym: GENESISII
StatusRecruiting
PhaseNot applicable
Started2022-10-30
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This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2022-06-13; most recent amendment 2024-11-28. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-10-28
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT05423587
Lead Sponsor Varian, a Siemens Healthineers Company
Conditions Knee Osteoarthritis
Enrollment 110 participants
Start Date 2022-10-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-03