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

A Single-arm, Single-center, Open-label, Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Transcatheter Arterial Micro-Embolization

Detailed Description

This clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of Nexsphere-F for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments.

In addition, through this clinical trial, complications of embolization and Nexsphere-F and It checks the safety of side effects. Therefore, in this study, TAME treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah VAS score reductions and QuickDASH scores, PRTEE score primary 6 Evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. For patients with chronic wrist pain, VAS score after 2 to 7 days, 1 month, 3 months, and 6 months of TAME treatment QuickDASH score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of Nexsphere-F by evaluating whether abnormal cases occur during the period.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang Woo Park; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr
• Study Contact Backup: Name: Jin Ho Hwang; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Study Locations

• Korea, Republic of
  • Kwang Jin Gu
    • Seoul, Kwang Jin Gu, Korea, Republic of, 120-1
      • Recruiting
      • Konkuk Hospital
      • Contact: Sang Woo Park; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Those aged 19 to 80
2. Anyone who can provide a consent form
3. A person with a life expectancy of at least 12 months
4. Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
5. VAS score of 4 or higher and moderate-severe elbow or wrist pain

Exclusion Criteria:

1. Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
2. Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)
3. allergy to iodide contrast agents that do not respond to steroids
4. Those with acute infection or malignancy
5. Those who have previously had elbow or wrist surgery
6. Those with Bleeding Diabetes that cannot be calibrated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.	Device: Transcatheter Arterial Micro-Embolization; Participants will undergo TAME with Nexsphere-F.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2~7days,1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of reduction of medication	The rate of change of medication before and after application of medical devices for clinical trials.	6 months
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).)	2~7days,1 month, 3 months, 6 months
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.))	2~7days,1 month, 3 months, 6 months
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).)	2~7days,1 month, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal cases during follow-up	Abnormal cases that occurred after the application of medical devices for clinical trials	1day ,2~7days,1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Sang Woo Park, Konkuk Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NS-F TAME002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No