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NCT Number: NCT06477965

Embo Registry; National Registry for Artery Embolization

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.

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Key information

Conditions

Chronic Pain Arthritis Joint Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis Shoulder Osteoarthritis Thumb Osteoarthritis, Knee Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Tendinopathy Tendon Injuries Tendonitis Elbow Tendonitis Shoulder Tendonitis;Achilles Tenosynovitis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular Solutions of North Carolina, Cary, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.

Exclusion criteria

  • None

Treatment and study plan

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.

Other names: Genicular Artery Embolization, GAE

Primary outcomes

  1. Primary Outcome

    Time frame: 3 months

    Clinical success at 3 months, defined as improvement in Western Ontario and McMaster University (WOMAC) Pain Subscale from pre-operative/baseline WOMAC scores.

  2. Primary Outcome

    Time frame: 3 months

    Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores.

  3. Primary Outcome

    Time frame: 3 months

    Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively.

  4. Primary Outcome

    Time frame: 3 months

    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.

Secondary outcomes

  1. Secondary Outcome

    Time frame: 12 months

    Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure.

  2. Secondary Outcome

    Time frame: 12 months

    Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months.

  3. Secondary Outcome

    Time frame: 12 months

    Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months.

  4. Secondary Outcome

    Time frame: 12 months

    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.

  5. Secondary Outcome

    Time frame: 12 months

    Change in the use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's) compared to baseline through 1, 3, 6, and 12 months.

  6. Secondary Outcome

    Time frame: 12 months

    Change in quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline through 1, 3, 6, and 12 months.

  7. Secondary Outcome

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amer Iqbal

CONTACT

[email protected]

919-897-5999

Meaghan Thomas, CCRP

CONTACT

[email protected]

9198975999

Sponsors and collaborators

Lead sponsor

Vascular Solutions of North Carolina

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jun 27, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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