Embo Registry; National Registry for Artery Embolization

Part of paid clinical trials in Cary, North Carolina.

Sponsor
Vascular Solutions of North Carolina
Study ID
NCT06477965
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Jun 2024
Primary completion
Jul 15, 2027
Completion
Jul 15, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Primary Outcome [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Vascular Solutions of North CarolinaCaryNorth Carolina27518
Meaghan Thomas, CCRP
[email protected]
9319677227
Amer Iqbal
[email protected]
Siddhartha Rao, MD
Southern Tennessee CardiologyWinchesterTennessee37398
Billie Clark
[email protected]
Mircea Basaraba, MD

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