Osteo Arthritis KneeSURENCT06550024
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
A study testing SakuraBead Resorbable Microspheres and Corticosteroid Injection in people with Osteo Arthritis Knee and Joint Diseases, run by CrannMed at 8 sites in 4 countries.
Trial summary
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases
- What is being tested?
- SakuraBead Resorbable Microspheres and Corticosteroid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 28 Nov 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject is able and willing to provide written informed consent, and
- Clinical diagnosis of knee OA, and
- Moderate to severe knee pain (WOMAC Pain ≥ 10), and
- Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
- Age ≥ 40 years and < 80 years, and
- Able to comply with all treatments and follow-up visits.
Who cannot join
- Severe knee OA (Kellgren-Lawrence grade 4), or
- Current infection of target joint, or
- Life expectancy less than 36 months, or
- Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
- Prior knee replacement surgery in the target knee, or
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- Pain score of >3 NRS on the non-target knee, or
- An acute internal derangement of the target knee, or
- History of uncorrectable coagulopathy, or
- Prior iodinated contrast reaction resulting in anaphylaxis, or
- Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
- Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
- Contraindication to MRI, or
- At the discretion of the Principal Investigator
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
University of Alabama Medicine
Birmingham, Alabama, 35233
IR Centers
Leesburg, Virginia, 20176
Advanced Vascular Institute
Panama City, Florida, 32405
IR Centers
Raleigh, North Carolina, 27617
Harbor UCLA Medical Center
Torrance, California, 90502
United Kingdom1 site
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
About this study
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Read the detailed description
To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.
- Conditions
- Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis
- Being tested
- SakuraBead Resorbable Microspheres, Corticosteroid Injection
- Keywords
- Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
- Medical subject headings
- Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SakuraBead Resorbable MicrospheresDevice
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Corticosteroid InjectionDrug
Corticosteroid injection in the knee
| Study group | Role | What they receive |
|---|---|---|
| Genicular Artery Embolization (GAE) | Experimental | Temporary Embolization of Genicular Arteries using Resorbable Microspheres Receives: Device: SakuraBead Resorbable Microspheres |
| Corticosteroid Injection | Active comparator | Corticosteroid injection in the knee Receives: Drug: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint - Proportion of Responders
Compare the proportion of responders* (defined as ≥50% reduction in WOMAC Pain score and ≥2 point reduction in NRS*) between the Investigational procedure and Control at 6 months.
- Non-responders will include subjects experiencing device-related SAEs. Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome *NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).
Measured: 6 Months
Primary Safety Endpoint - Freedom from treatment-related SAEs
Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).
Measured: 6 Months
Secondary outcomes (3)
Proportion of Responders at 1 Month and 3 Month
Compare the proportion of responders* (defined as ≥50% reduction in WOMAC Pain score and ≥2 point reduction in NRS*) between the Investigational procedure and Control at 1 Month and 3 Months.
- Non-responders will include subjects experiencing device-related SAEs. Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome *NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).
Measured: 1 Month and 3 Months
Change in mean WOMAC Pain
Compare mean change from baseline in the Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain, Scale: 0-20, where a lower score represents a better outcome) between the Investigational procedure and Control at 1 Month, 3 Months and 6 Months.
Measured: 1 Month, 3 Months and 6 Months
Change in Numeric Rating Scale (NRS)
Compare mean decrease in pain (measured using the Numeric Rating Scale (NRS)) between the Investigational procedure and Control at 1 month, 3 months and 6 months. Scale: 0-10, where a lower score means a better outcome.
Measured: 1 Month, 3 Months and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start28 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CrannMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550024
- Sponsor's protocol ID
- CI570
- Acronym
- SURE
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2024
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
- ClinicalTrials.gov ID
- NCT06550024
- Acronym / sponsor ID
- SURE / CI570
- Conditions
- Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis
- Keywords
- Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- CrannMedIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Aug 2024 (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.
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Detailed description
To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular Artery Embolization (GAE) | Experimental | Device: SakuraBead Resorbable MicrospheresTemporary Embolization of Genicular Arteries using Resorbable Microspheres |
| Corticosteroid Injection | Active comparator | Drug: Corticosteroid InjectionCorticosteroid injection in the knee |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able and willing to provide written informed consent, and
- Clinical diagnosis of knee OA, and
- Moderate to severe knee pain (WOMAC Pain ≥ 10), and
- Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
Key exclusion criteria (14 listed)
- Severe knee OA (Kellgren-Lawrence grade 4), or
- Current infection of target joint, or
- Life expectancy less than 36 months, or
- Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
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 |
|---|---|---|
| SakuraBead Resorbable MicrospheresTemporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres | Device | Genicular Artery Embolization (GAE) |
| Corticosteroid InjectionCorticosteroid injection in the knee | Drug | Corticosteroid Injection |
Primary outcome
Primary Efficacy Endpoint - Proportion of Responders
Time frame: 6 Months
Compare the proportion of responders* (defined as ≥50% reduction in WOMAC Pain score and ≥2 point reduction in NRS*) between the Investigational procedure and Control at 6 months. * Non-responders will include subjects experiencing device-related SAEs. Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome *NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).
Primary Safety Endpoint - Freedom from treatment-related SAEs
Time frame: 6 Months
Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).
3 secondary outcomes
Proportion of Responders at 1 Month and 3 Month
Time frame: 1 Month and 3 Months
Change in mean WOMAC Pain
Time frame: 1 Month, 3 Months and 6 Months
Change in Numeric Rating Scale (NRS)
Time frame: 1 Month, 3 Months and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SakuraBead Resorbable Microspheres and Corticosteroid Injection in people with Osteo Arthritis Knee and Joint Diseases, run by CrannMed at 8 sites in 4 countries.
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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Georgia, United Kingdom, Uzbekistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Efficacy Endpoint - Proportion of Responders (time frame: 6 Months). The study lists 2 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 30 Oct 2026.