Embo Registry; National Registry for Artery Embolization

NCT ID: NCT06477965

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2029-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Osteoarthritis, Knee Osteoarthritis Thumb Osteoarthritis Shoulder Pain, Chronic Tendonitis Elbow Tendonitis Shoulder Tendonitis;Achilles Tenosynovitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

Artery Embolization

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Genicular Artery Embolization GAE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vascular Solutions of North Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siddhartha Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Solutions of North Carolina

Amer Iqbal

Role: STUDY_DIRECTOR

Vascular Solutions of North Carolina

Meaghan Thomas, CCRP

Role: STUDY_CHAIR

Vascular Solutions of North Carolina

Locations

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Vascular Solutions of North Carolina

Cary, North Carolina, United States

Site Status RECRUITING

Southern Tennessee Cardiology

Winchester, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amer Iqbal

Role: CONTACT

919-897-5999

Meaghan Thomas, CCRP

Role: CONTACT

9198975999

Facility Contacts

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Meaghan Thomas, CCRP

Role: primary

9319677227

Amer Iqbal

Role: backup

Siddhartha Rao, MD

Role: backup

Billie Clark

Role: primary

Mircea Basaraba, MD

Role: backup

Related Links

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Other Identifiers

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20241915

Identifier Type: -

Identifier Source: org_study_id

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