Recruiting

Embo Registry

Sponsor:

Vascular Solutions of North Carolina

Code:

NCT06477965

Conditions

Chronic Pain

Osteoarthritis, Knee

Osteoarthritis Thumb

Osteoarthritis Shoulder

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Artery Embolization

Study Details

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.

Conditions

Chronic Pain

Osteoarthritis, Knee

Osteoarthritis Thumb

Osteoarthritis Shoulder

Pain, Chronic

Study ID

NCT06477965

Start date

Jul 15, 2024

Status verified date

Jun, 2024

Completion date

Jul 15, 2029

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Primary Outcome [ Time Frame: 3 months ]
  • Primary Outcome [ Time Frame: 3 months ]
  • Primary Outcome [ Time Frame: 3 months ]
  • Primary Outcome [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Vascular Solutions of North Carolina

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Southern Tennessee Cardiology

Recruiting

Winchester, Tennessee, United States, 37398

Contacts

More Information

Sponsor

Vascular Solutions of North Carolina

Last update posted

Oct 28, 2024

Last verified

Jun, 2024

Keywords

  • Pain
  • Osteoarthritis
  • Arthritis
  • Tendonitis
  • Tenosynovitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vascular Solutions of North Carolina on 2024-10-28.