Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embozene MicroSpheres | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Treatment-related AEs from gennicular artery embolization during the study period | Up to 12 Months after GAE |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:• Mild knee pain as determined by visual analog scale < 4
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Siddharth Padia, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siddharth Padia, M.D. | Santa Monica | California | 90404 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of 65 individuals assessed for eligibility, 20 did not meet inclusion criteria and 5 declined to participate
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Genicular Artery Embolization (GAE) With Embozene Microspheres | Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genicular Artery Embolization (GAE) With Embozene Microspheres | Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Treatment-related AEs from gennicular artery embolization during the study period | Posted | Count of Participants | Participants | Up to 12 Months after GAE |
|
|
12 months
Adverse Events were recorded, per protocol, only if determined to be at least possibly related to study intervention
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genicular Artery Embolization (GAE) With Embozene Microspheres | Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Focal skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siddharth A. Padia, MD | University of California Los Angeles | 310-825-2992 | SPadia@mednet.ucla.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2020 | Aug 10, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008863 | Microspheres |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
Not provided
Not provided
The stratification will not be randomized, but each category will be limited to 20 patients.
Not provided
Not provided
Not provided
Not provided
|
|
| 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. | 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). | Baseline, Month 1, Month 3, Month 6, Month 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index (BMI) is a simple calculation of kg/m^2 where kg is a person's weight in kilograms and m^2 is their height in metres squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9. | Median | Full Range | kg/m^2 |
|
| WOMAC Index | The The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index 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). Possible score range 0-96. Higher scores indicate worse pain, stiffness, and functional limitations. | Median | Full Range | units on a scale |
|
| WOMAC Pain Score | The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale quantifies knee pain severity with activities of daily living. The WOMAC pain scale asks the patient to rate the extent of pain in the involved knee/hip during activities. The WOMAC pain scale ranges from 0 (no pain with all 5 activities, ie, flat surface walking, stairclimbing, at night, sitting or lying, standing) to 20 (extreme pain with all 5 activities). | Median | Full Range | units on a scale |
|
| Visual Analog Scale (VAS) pain score | The 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). | Median | Full Range | units on a scale |
|
|
|
| Secondary | 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 | Posted | Median | Full Range | score on a scale | Baseline, Month 1, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | score on a scale | Baseline, Month 1, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | score on a scale | Baseline, Month 1, Month 3, Month 6, Month 12 |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 9 |
| 40 |
| Asymptomatic bone infarct | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Month 12 |
|
| Title | Measurements |
|---|---|
|
| Month 12 |
|
| Title | Measurements |
|---|---|
|
| Month 12 |
|