An observational study in Chronic Pain, Osteoarthritis, Knee and Osteoarthritis Thumb, sponsored by Vascular Solutions of North Carolina. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Vascular Solutions of North Carolina · Observational
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →This is the only study on the registry with Vascular Solutions of North Carolina as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Artery Embolization
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.
Also known as: Genicular Artery Embolization, GAE
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.
Time frame: 3 months
Primary Outcome
Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores.
Time frame: 3 months
Primary Outcome
Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively.
Time frame: 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.
Time frame: 3 months
Secondary Outcome
Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure.
Time frame: 12 months
Secondary Outcome
Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months.
Time frame: 12 months
Secondary Outcome
Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: Yes — 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.
Supporting information: Clinical study report
Time frame: 12 months
Access criteria: Must contact sponsor for approval or participate in study research.
Data sharing details ↗ · emboregistry.ai
Started Jul 2024 (actual). Primary completion is estimated for Jul 2027, 36 months after the start.
Of 336 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 36 months is above that.
Counting every sponsor, half of 362 studies reached it within 24 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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