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Genicular Artery Embolisation for Knee Osteoarthritis II

Study acronym: GENESISII
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2027
    • Start date: Sep 30, 2022 to Oct 30, 2022
    • Study completion date: Feb 8, 2026 to Jun 30, 2028
    v5
  2. Secondary endpoints: details revised at 1 of 3 entriesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2022 to Sep 30, 2022
    • Site details revised
    v3
  4. Start date: Jul 1, 2022 to Sep 1, 2022
    • Interventions: Genicular Artery Embolization (Procedure), Genicular Artery Injection (Procedure) to Genicular Artery Embolisation (Procedure), Genicular Artery Injection (Procedure)
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05423587
Lead Sponsor Varian, a Siemens Healthineers Company
Conditions
(from sponsor)		 Knee Osteoarthritis
Related terms Joint Diseases, Osteoarthritis, Knee
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov