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NCT05423587: GENESISII

Genicular Artery Embolisation for Knee Osteoarthritis II

Recruiting now NA Last updated 3 December 2024
What this trial tests

NA trial testing Genicular Artery Embolisation in Knee Osteoarthritis in 110 participants. Currently enrolling.

Timeline
30 October 2022
Primary endpoint
31 December 2027
30 June 2028

Quick facts

Lead sponsorVarian, a Siemens Healthineers Company
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment110
Start date30 October 2022
Primary completion31 December 2027
Estimated completion30 June 2028
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Varian, a Siemens Healthineers Company — full company profile →

Who can join

45 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial.
    Little MW, Harrison R, MacGill S, Speirs A, et al · · 2023 · cited 9× · PMID 37337060 · DOI 10.1007/s00270-023-03477-z
  2. Surgical and nonsurgical treatment of hip and knee osteoarthritis: a 2026 perspective
    LAIGAARD J, MALEITZKE T, SKOU S, MECHLENBURG I, et al · · 2026

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Varian, a Siemens Healthineers Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05423587.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing