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Embolization Agent
Artery Embolization for Knee Osteoarthritis (GRAVITY Trial)
N/A
Recruiting
Led By Siddharth Padia, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
Ineligibility for or refusal of surgical management
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-24 months
Awards & highlights
GRAVITY Trial Summary
This trial is testing whether a new procedure, genicular artery embolization, is an effective way to treat knee pain from osteoarthritis by reducing blood flow to the area of pain.
Who is the study for?
This trial is for adults aged 40-79 with moderate to severe knee pain from osteoarthritis, who haven't had success with standard treatments like NSAIDs or joint injections. Participants should have a Kellgren-Lawrence score >2 and be ineligible for or refuse surgery. Exclusions include certain medical conditions, allergies, pregnancy, recent smoking history, and previous knee replacements.Check my eligibility
What is being tested?
The study tests if genicular artery embolization (GAE), which reduces blood flow to the painful area of the knee using Embozene MicroSpheres during an angiogram procedure, can alleviate arthritis pain compared to no intervention. It's a randomized trial where two-thirds of participants will undergo GAE and one-third will not.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site in the thigh crease due to angiogram pinhole entry, allergic reactions to materials used such as contrast agents or microspheres, temporary numbness or bruising around the treated area.
GRAVITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain is more than 5 out of 10 on a pain scale.
Select...
I cannot or do not want to undergo surgery for my condition.
Select...
I am between 40 and 79 years old.
GRAVITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in clinical response
Secondary outcome measures
Change in MRI
Change in inflammatory biomarkers
Change in quality of life
+8 moreGRAVITY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GAE TreatmentExperimental Treatment1 Intervention
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.
Group II: ObservationalActive Control1 Intervention
Subjects randomized to the observational group will not undergo the experimental GAE Treatment.
PI will offer subjects enrolled into the observational group to crossover to the experimental GAE Treatment group after they have completed their 6-month follow-up assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Embozene MicroSpheres
2019
N/A
~40
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,168 Total Patients Enrolled
3 Trials studying Osteoarthritis
812 Patients Enrolled for Osteoarthritis
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,679 Total Patients Enrolled
1 Trials studying Osteoarthritis
120 Patients Enrolled for Osteoarthritis
Siddharth Padia, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have smoked cigarettes in the past year or currently smoke.My knee X-ray shows severe OA with significant bending.I have severe artery blockage that could affect heart imaging tests.I have had a knee replacement surgery on my affected knee.I do not have an active infection or another type of cancer.My condition did not improve after 3 months of standard treatments like painkillers, physical therapy, or joint injections.My X-ray shows I have moderate to severe osteoarthritis.I have had surgery or injections in my lower back or have had leg pain originating from my spine.My kidney function is moderately reduced.My knee pain is more than 5 out of 10 on a pain scale.I cannot or do not want to undergo surgery for my condition.I am between 40 and 79 years old.You have a bleeding disorder that cannot be treated or fixed.I have a history of fibromyalgia, autoimmune, or inflammatory disorder.My knee pain is mild, scoring less than 5 on a pain scale.
Research Study Groups:
This trial has the following groups:- Group 1: GAE Treatment
- Group 2: Observational
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment only cater to those under 30?
"This trial is only open for patients that are 40 to 80 years old."
Answered by AI
How can potential participants sign up for this research project?
"Unfortunately, this specific trial is not presently looking for new participants. The study was first announced on October 1st, 2022 but was last updated on August 24th, 2022. There are, however, 817 other clinical trials that are actively recruiting patients."
Answered by AI
What medical goal does this research hope to achieve?
"The purpose of this 24-month study is to compare changes in clinical response between the treatment and control groups. Secondary outcomes include changes in the MRI [Osteoarthritis knee](https://www.withpower.com/clinical-trials/osteoarthritis-knee) Score (MOAKS) score, degree of progression of osteoarthritis, and clinical outcomes at multiple timepoints."
Answered by AI
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