Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorNext Biomedical Co., Ltd.

About this trial

In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those aged 19 to 80

Anyone who can provide a consent form

A person with a life expectancy of at least 12 months

Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)

Disqualifiers

Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain

Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)

allergy to iodide contrast agents that do not respond to steroids

Those with acute infection or malignancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcatheter Arterial Micro-Embolization

    Device

    Participants will undergo TAME with Nexsphere-F.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of subjects with a 50% or more reduction in QuickDASH Score Change

Descriptive statistics (mean, standard deviation, median, minimum and maximum) are presented for each visit compared to the average change rate baseline of the QuickDASH score before and after clinical trial medical device application.

Time frame
2~7days,1 month, 3 months, 6 months

Secondary outcomes

1

Rate of VAS Score (patient pain intensity) Change

The rate of change of VAS Score (patient pain intensity)Score before and after application of medical devices for clinical trials.(The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).)

Time frame
2~7days,1 month, 3 months, 6 months
2

Rate of Changes in symptoms according to in QuickDASH Score

The rate of change of QuickDASH Score before and after application of medical devices for clinical trials.(Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaires. QuickDASH scores range from 0 (no disability) to 100 (most severe disability.))

Time frame
2~7days,1 month, 3 months, 6 months
3

Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score

The rate of change of Patient-Rated Tennis Elbow Evaluation (PRTEE) Score before and after application of medical devices for clinical trials.((Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score).)

Time frame
2~7days,1 month, 3 months, 6 months
4

The rate of reduction of medication

The rate of change of medication before and after application of medical devices for clinical trials.

Time frame
6 months

Other outcomes

1

Number of participants with abnormal cases during follow-up

Abnormal cases that occurred after the application of medical devices for clinical trials

Time frame
1day ,2~7days,1 month, 3 months, 6 months

Sponsors and contacts

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