Knee OsteoarthritisNCT04472091
Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
A study testing Genicular artery embolization (GAE) in people with Knee Osteoarthritis and Knee Pain Chronic, run by Andrew Picel at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling
- What is being tested?
- Genicular artery embolization (GAE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent
- Age ≥ 40 years
- Moderate to severe knee pain (VAS >40 mm)
- Pain refractory to 3 months of conservative treatments, including at least one of the following:
- a. Anti-inflammatory medications
- b. Physical therapy
Show all 11Show fewer
- c. Intra-articular injections
- Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
- MRI features of active synovitis (synovial thickening and/or enhancement on MRI).
- Ineligibility or refusal of surgical management.
- Local knee tenderness
Who cannot join
- Rheumatoid or infectious arthritis
- Advanced lower extremity atherosclerosis that would limit selective angiography
- Local knee infection
- Prior knee surgery (excluding arthroscopic/meniscal interventions)
- Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)
- Iodine allergy resulting in anaphylaxis
- Chronic renal insufficiency (serum creatinine >2 mg/dL)
- Life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
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.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion
- Being tested
- Genicular artery embolization (GAE)
- Keywords
- Knee osteoarthritis, Genicular artery embolization, Geniculate artery embolization
- Medical subject headings
- Osteoarthritis, Knee, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular artery embolization (GAE)Device
Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).
| Study group | Role | What they receive |
|---|---|---|
| Genicular artery embolization | Experimental | Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE. Receives: Device: Genicular artery embolization (GAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 1 month post GAE
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 6 months post GAE
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 12 months post GAE
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 24 months post GAE
Secondary outcomes (8)
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Measured: Baseline to 1 month post GAE
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Measured: Baseline to 6 months post GAE
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Measured: Baseline to 12 months post GAE
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Measured: Baseline 24 months post GAE
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Measured: Baseline to 1 month post GAE
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Measured: Baseline to 6 months post GAE
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Measured: Baseline to 12 months post GAE
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Measured: Baseline to 24 months post GAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start15 Jan 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Why it stopped: No Insurance Coverage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Picel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Picel, Stanford University
- Investigators
- Andrew C Picel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472091
- Sponsor's protocol ID
- 57046
- Other IDs
- IDE G200111
- Status last verified
- Feb 2025
- First submitted
- 9 Jul 2020
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
- ClinicalTrials.gov ID
- NCT04472091
- Acronym / sponsor ID
- 57046
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion
- Keywords
- Knee osteoarthritis, Genicular artery embolization, Geniculate artery embolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Insurance Coverage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrew PicelUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genicular artery embolization | Experimental | Device: Genicular artery embolization (GAE)Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide informed consent
- Age ≥ 40 years
- Moderate to severe knee pain (VAS >40 mm)
- Pain refractory to 3 months of conservative treatments, including at least one of the following:
- Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
Key exclusion criteria (8 listed)
- Rheumatoid or infectious arthritis
- Advanced lower extremity atherosclerosis that would limit selective angiography
- Local knee infection
- Prior knee surgery (excluding arthroscopic/meniscal interventions)
- Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular artery embolization (GAE)Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). | Device | Genicular artery embolization |
Primary outcome
Number of patients with treatment related adverse events
Time frame: 1 month post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Time frame: 6 months post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Time frame: 12 months post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Time frame: 24 months post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
8 secondary outcomes
Mean change from baseline pain scores
Time frame: Baseline to 1 month post GAE
Mean change from baseline pain scores
Time frame: Baseline to 6 months post GAE
Mean change from baseline pain scores
Time frame: Baseline to 12 months post GAE
Mean change from baseline pain scores
Time frame: Baseline 24 months post GAE
Mean change from baseline knee function scores
Time frame: Baseline to 1 month post GAE
Mean change from baseline knee function scores
Time frame: Baseline to 6 months post GAE
Mean change from baseline knee function scores
Time frame: Baseline to 12 months post GAE
Mean change from baseline knee function scores
Time frame: Baseline to 24 months post GAE
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew C Picel, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular artery embolization (GAE) in people with Knee Osteoarthritis and Knee Pain Chronic, run by Andrew Picel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related adverse events (time frame: 1 month post GAE). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.