RECRUITING

SakuraBead Used As Resorbable Embolic for Genicular Artery Embolization

Conditions

Osteo Arthritis Knee Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Arthritis Osteoarthritis Genicular Artery Embolization GAE Knee Embolization Knee OA Knee Osteoarthritis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Official Title

SakuraBead Used As Resorbable Embolic for Genicular Artery Embolization

Quick Facts

Study Start:2024-11

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06550024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is able and willing to provide written informed consent, and 2. Clinical diagnosis of knee OA, and 3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and 4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and 5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and 6. Age ≥ 40 years and \< 80 years, and 7. Able to comply with all treatments and follow-up visits.	1. Severe knee OA (Kellgren-Lawrence grade 4), or 2. Current infection of target joint, or 3. Life expectancy less than 36 months, or 4. 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 5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or 6. Prior knee replacement surgery in the target knee, or 7. Pain score of \>3 NRS on the non-target knee, or 8. An acute internal derangement of the target knee, or 9. History of uncorrectable coagulopathy, or 10. Prior iodinated contrast reaction resulting in anaphylaxis, or 11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or 12. 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 13. Contraindication to MRI, or 14. At the discretion of the Principal Investigator

Inclusion Criteria

Exclusion Criteria

1. Subject is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age ≥ 40 years and \< 80 years, and
7. Able to comply with all treatments and follow-up visits.

1. Severe knee OA (Kellgren-Lawrence grade 4), or
2. Current infection of target joint, or
3. Life expectancy less than 36 months, or
4. 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
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Pain score of \>3 NRS on the non-target knee, or
8. An acute internal derangement of the target knee, or
9. History of uncorrectable coagulopathy, or
10. Prior iodinated contrast reaction resulting in anaphylaxis, or
11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
12. 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
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator

Contacts and Locations

Study Contact

Chief Operations Officer

CONTACT

+1 800 353 4246

joan.mccabe@crannmed.com

Study Locations (Sites)

IR Centers

Raleigh, North Carolina, 27617

United States

Collaborators and Investigators

Sponsor: CrannMed

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-11

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Genicular Artery Embolization
GAE
Knee Embolization
Knee OA
Knee Osteoarthritis

Additional Relevant MeSH Terms

Osteo Arthritis Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthritis
Osteoarthritis