Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06207851
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with abnormal cases during follow-up', 'timeFrame': '1day ,2~7days,1 month, 3 months, 6 months', 'description': 'Abnormal cases that occurred after the application of medical devices for clinical trials'}], 'primaryOutcomes': [{'measure': 'Rate of subjects with a 50% or more reduction in QuickDASH Score Change', 'timeFrame': '2~7days,1 month, 3 months, 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rate of VAS Score (patient pain intensity) Change', 'timeFrame': '2~7days,1 month, 3 months, 6 months', 'description': '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).)'}, {'measure': 'Rate of Changes in symptoms according to in QuickDASH Score', 'timeFrame': '2~7days,1 month, 3 months, 6 months', 'description': '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.))'}, {'measure': 'Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score', 'timeFrame': '2~7days,1 month, 3 months, 6 months', 'description': '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).)'}, {'measure': 'The rate of reduction of medication', 'timeFrame': '6 months', 'description': 'The rate of change of medication before and after application of medical devices for clinical trials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those aged 19 to 80\n2. Anyone who can provide a consent form\n3. A person with a life expectancy of at least 12 months\n4. Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)\n5. VAS score of 4 or higher and moderate-severe elbow or wrist pain\n\nExclusion Criteria:\n\n1. Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain\n2. Chronic Renal Insufficiency(Serum creatinine \\> 2mg/dL)\n3. allergy to iodide contrast agents that do not respond to steroids\n4. Those with acute infection or malignancy\n5. Those who have previously had elbow or wrist surgery\n6. Those with Bleeding Diabetes that cannot be calibrated'}, 'identificationModule': {'nctId': 'NCT06207851', 'briefTitle': 'Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist', 'organization': {'class': 'INDUSTRY', 'fullName': 'Next Biomedical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NS-F TAME002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.', 'interventionNames': ['Device: Transcatheter Arterial Micro-Embolization']}], 'interventions': [{'name': 'Transcatheter Arterial Micro-Embolization', 'type': 'DEVICE', 'description': 'Participants will undergo TAME with Nexsphere-F.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-1', 'city': 'Seoul', 'state': 'Kwang Jin Gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Woo Park', 'role': 'CONTACT', 'email': 'next@nextbiomedical.co.kr', 'phone': '+82-32-454-4800'}], 'facility': 'Konkuk Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang Woo Park', 'role': 'CONTACT', 'email': 'next@nextbiomedical.co.kr', 'phone': '+82-32-454-4800'}, {'name': 'Jin Ho Hwang', 'role': 'CONTACT', 'email': 'next@nextbiomedical.co.kr', 'phone': '+82-32-454-4800'}], 'overallOfficials': [{'name': 'Sang Woo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Next Biomedical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}