Embo Registry; National Registry for Artery Embolization

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVascular Solutions of North Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Artery Embolization

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

Primary Outcome

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

Time frame
3 months
3

Primary Outcome

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

Time frame
3 months
4

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.

Time frame
3 months

Secondary outcomes

1

Secondary Outcome

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

Time frame
12 months
2

Secondary Outcome

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

Time frame
12 months
3

Secondary Outcome

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

Time frame
12 months
4

Secondary Outcome

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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