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Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Study Purpose

The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject has signed informed consent.
  • - Subject is age 40-80.
  • - Subject is able to have an MRI.
  • - Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of: a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
  • - Localized tenderness in anterior knee area.
  • - Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs.
  • - Synovitis present as assessed by WORMS.
  • - VAS >50 mm.
  • - WOMAC score >30.

Exclusion Criteria:

  • - Rheumatoid arthritis.
  • - Local infection of the target knee(s) - Kellgren-Lawrence grade >3.
  • - Osteonecrosis evident by MRI.
  • - Prior knee arthroplasty.
  • - Allergy to iodinated contrast agents that cannot be managed by prophylaxis.
  • - Hypersensitivity to gelatin products.
  • - Any known condition that limits catheter-based intervention or is a contraindication to embolization.
  • - Active malignancy other than non-melanomatous skin cancer.
  • - Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant.
- Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05112926
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Shivank Bhatia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Shivank Bhatia
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis
Arms & Interventions

Arms

Experimental: Embosphere Microspheres group

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

Interventions

Device: - Embosphere Microspheres

Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Lia Quezada

[email protected]

305-243-2210

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