Embo Registry; National Registry for Artery Embolization
Multicenter National Registry for Artery Embolization (Embo Registry) for the Treatment of Osteoarthritis and Areas of Localized Pain to Assess Treatment of Artery Embolization to Determine If Subjects Have Decrease Pain, Decreased Use of Narcotics and NSAIDs, and Quality of Life Improvement Post Procedure.
1 other identifier
observational
1,000
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2029
October 28, 2024
June 1, 2024
3 years
June 21, 2024
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (7)
Secondary Outcome
12 months
Secondary Outcome
12 months
Secondary Outcome
12 months
Secondary Outcome
12 months
Secondary Outcome
12 months
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- \> 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Vascular Solutions of North Carolina
Cary, North Carolina, 27518, United States
Southern Tennessee Cardiology
Winchester, Tennessee, 37398, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siddhartha Rao, MD
Vascular Solutions of North Carolina
- STUDY DIRECTOR
Amer Iqbal
Vascular Solutions of North Carolina
- STUDY CHAIR
Meaghan Thomas, CCRP
Vascular Solutions of North Carolina
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
July 15, 2024
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
July 15, 2029
Last Updated
October 28, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 12 months
- Access Criteria
- Must contact sponsor for approval or participate in study research.
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.