Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
WithdrawnNot applicableNCT04472091
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.
Study details
- Official title
- Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
- Conditions
- Knee Osteoarthritis
- Knee Pain Chronic
- Knee Pain Swelling
- Knee Arthritis
- Arterial Occlusion
- Interventions
- Device: Genicular artery embolization (GAE)
- Sponsor
- Andrew Picel
- Organization
- Stanford University
- Start date
- 2025-01-15
- Primary completion
- 2026-11-01
- Sex
- All
- Age range
- from 40 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Provide informed consent 2. Age ≥ 40 years 3. Moderate to severe knee pain (VAS \>40 mm) 4. Pain refractory to 3 months of conservative treatments, including at least one of the following: * a. Anti-inflammatory medications * b. Physical therapy * c. Intra-articular injections 5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease 6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI). 7. Ineligibility or refusal of surgical management. 8. Local knee tenderness Exclusion Criteria: 1. Rheumatoid or infectious arthritis 2. Advanced lower extremity atherosclerosis that would limit selective angiography 3. Local knee infection 4. Prior knee surgery (excluding arthroscopic/meniscal interventions) 5. Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL) 6. Iodine allergy resulting in anaphylaxis 7. Chronic renal insufficiency (serum creatinine \>2 mg/dL) 8. Life expectancy less than 6 months
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04472091