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Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.
Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. For the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group | For the study to determine efficacy and overall improvement of patients post artery embolization by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artery Embolization | Procedure | Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Clinical success at 3 months, defined as improvement in Western Ontario and McMaster University (WOMAC) Pain Subscale from pre-operative/baseline WOMAC scores. | 3 months |
| Primary Outcome | Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores. | 3 months |
| Primary Outcome | Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively. | 3 months |
| Primary Outcome | Clinical success at 3 months, as defined by improvement in the quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure. | 12 months |
| Secondary Outcome | Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic and localized pain from diagnoses such as osteoarthritis, tendonitis, tenosynovitis, or injury who underwent Artery Embolization for the treatment of their symptoms/pain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amer Iqbal | Contact | 919-897-5999 | amer@vascularsolutions.org | |
| Meaghan Thomas, CCRP | Contact | 9198975999 | meaghan@vascularsolutions.org |
| Name | Affiliation | Role |
|---|---|---|
| Siddhartha Rao, MD | Vascular Solutions of North Carolina | Principal Investigator |
| Amer Iqbal | Vascular Solutions of North Carolina | Study Director |
| Meaghan Thomas, CCRP |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Solutions of North Carolina | Recruiting | Cary | North Carolina | 27518 | United States |
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| Label | URL |
|---|---|
| contact study | View source |
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Dissemination of data will be through publications in peer-reviewed scientific journals, national and international meeting, on-line presentations, and providing de-identified data to participating site investigators and by providing analysis results upon request from site investigators.
12 months
Must contact sponsor for approval or participate in study research.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D020370 | Osteoarthritis, Knee |
| D013717 | Tenosynovitis |
| D010146 | Pain |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D055357 | Uterine Artery Embolization |
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| 12 months |
| Secondary Outcome | Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months. | 12 months |
| Secondary Outcome | Number of subjects who had pain reduction >50% in the mean VAS pain scale at 1, 3, 6 and 12 months in comparison with baseline/preprocedural assessments. | 12 months |
| Secondary Outcome | Change in the use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's) compared to baseline through 1, 3, 6, and 12 months. | 12 months |
| Secondary Outcome | Change in quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline through 1, 3, 6, and 12 months. | 12 months |
| Secondary Outcome | Number of patients with confirmed cases of osteoarthritis with a Kellgren and Lawerence Grade Level 2-3 (confirmed by X-Ray) improved symptoms compared to baseline through to 1, 3, 6 and 12-months post procedure. | 12 months |
| Vascular Solutions of North Carolina |
| Study Chair |
| Southern Tennessee Cardiology | Recruiting | Winchester | Tennessee | 37398 | United States |
|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D013509 |
| Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |