Knee OsteoarthritisGAE-OANCT03491397
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
A study testing Embozene MicroSpheres in people with Knee Osteoarthritis and Degenerative Joint Disease of Knee, run by Siddharth Padia, MD at 1 site in United States.
Trial summary
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Knee Osteoarthritis, Degenerative Joint Disease of Knee
- What is being tested?
- Embozene MicroSpheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2019to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided informed consent
- Age ≥ 40 years and ≤ 80 years
- Life expectancy greater than 12 months
- Ineligibility for or refusal of surgical management
- Moderate-severe knee pain as determined by visual analog scale > 4
- Osteoarthritis based on xray
Show all 16Show fewer
- Local knee tenderness
- Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)
- Exclusion Criteria:• Mild knee pain as determined by visual analog scale < 4
- Chronic renal insufficiency (serum creatinine >2 mg/dL)
- Uncorrectable bleeding diathesis: international normalized ratio (INR) >1.6, Platelets <50,000
- Significant arterial atherosclerosis that would limit selective angiography
- Allergy to iodinated contrast agents that is not responsive to steroid management
- Active Infection or malignancy
- Appropriate candidate for knee replacement surgery determined by clinical and physical examination
- Recent (within 3 months) or active cigarette use
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Siddharth Padia, M.D.
Santa Monica, California, 90404
About this study
Official title: Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Read the detailed description
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
- Being tested
- Embozene MicroSpheres
- Keywords
- Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embozene MicroSpheresDevice
Also called Color-Advanced Microspheres, Microspheres for Embolization
Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
| Study group | Role | What they receive |
|---|---|---|
| GAE OA | Experimental | Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. Receives: Device: Embozene MicroSpheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Treatment-related AEs from gennicular artery embolization during the study period
Measured: Up to 12 Months after GAE
Secondary outcomes (3)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations.
Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
The WOMAC Pain Subscale is a self-administered questionnaire of 5 items to assess Pain: during walking, using stairs, in bed, sitting or lying, and standing upright.
Each item is scored on a scale of 0-4: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible total score range of 0-20.
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start10 Feb 2019
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- The stratification will not be randomized, but each category will be limited to 20 patients.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siddharth Padia, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Siddharth Padia, MD, University of California, Los Angeles
- Investigators
- Siddharth Padia, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491397
- Sponsor's protocol ID
- 18-000560
- Acronym
- GAE-OA
- Status last verified
- Nov 2022
- First submitted
- 23 Mar 2018
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03491397
- Acronym / sponsor ID
- GAE-OA / 18-000560
- Keywords
- Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Siddharth Padia, MDUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Detailed description
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The stratification will not be randomized, but each category will be limited to 20 patients.
| Arm | Type | Receives |
|---|---|---|
| GAE OA | Experimental | Device: Embozene MicroSpheresSubjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provided informed consent
- Age ≥ 40 years and ≤ 80 years
- Life expectancy greater than 12 months
- Ineligibility for or refusal of surgical management
- Moderate-severe knee pain as determined by visual analog scale > 4
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Embozene MicroSpheresAlso: Color-Advanced Microspheres, Microspheres for EmbolizationEmbozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee. | Device | GAE OA |
Primary outcome
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Time frame: Up to 12 Months after GAE
Treatment-related AEs from gennicular artery embolization during the study period
3 secondary outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Siddharth Padia, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embozene MicroSpheres in people with Knee Osteoarthritis and Degenerative Joint Disease of Knee, run by Siddharth Padia, MD 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 16 inclusion and 0 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: finished, as of the sponsor's last update on 30 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety (time frame: Up to 12 Months after GAE). 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 30 Nov 2022.