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

NCT06207851 | Recruiting

• 1 other identifier: NS-F TAME002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

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.

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

Secondary Outcomes (4)

• Rate of VAS Score (patient pain intensity) Change

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

• Rate of Changes in symptoms according to in QuickDASH Score

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

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

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

• The rate of reduction of medication

  6 months

Other Outcomes (1)

• Number of participants with abnormal cases during follow-up

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

Study Arms (1)

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

Interventions

Transcatheter Arterial Micro-Embolization DEVICE

Participants will undergo TAME with Nexsphere-F.

Experimental

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• VAS score of 4 or higher and moderate-severe elbow or wrist pain

You may not qualify if:

• 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
• Those who have previously had elbow or wrist surgery
• Those with Bleeding Diabetes that cannot be calibrated

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (1)

Konkuk Hospital

Seoul, Kwang Jin Gu, 120-1, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sang Woo Park

  Konkuk Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Woo Park

CONTACT

+82-32-454-4800; next@nextbiomedical.co.kr

Jin Ho Hwang

CONTACT

+82-32-454-4800; next@nextbiomedical.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: July 13, 2023
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-01

Locations

KR (1)