Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06040112
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant score (Shoulder function score)', 'timeFrame': '1, 3, 5 months', 'description': 'The Constant score is commonly used to evaluate the functional status of shoulder disorders and shows relatively high accuracy, reliability, and reproducibility. The evaluation is out of a total of 100 points: pain 15 points, daily activities 20 points, anterior elevation 10 points, lateral elevation 10 points, internal/external rotation each 10 points, and muscle strength 25 points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcific Tendinitis of Shoulder', 'Atelocollagen']}, 'descriptionModule': {'briefSummary': 'Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.', 'detailedDescription': 'Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure.\n\nCase group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.\n\nControl group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."\n\nClinical outcomes will be assessed with functional scores on 6 months after injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients in whom calcification of 5mm or more is observed in plain radiographs.\n2. In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.\n3. Individuals who have agreed to participate in this study and have given written consent themselves.\n\nExclusion Criteria:\n\n* Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.\n\n * Patients with hypersensitivity.\n\n * Patients with a history of anaphylactic reactions.\n\n * Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.\n\n * Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.\n\n ⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.\n\n ⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.\n\n ⑨ Patients who are on concomitant medications that include oral steroids.'}, 'identificationModule': {'nctId': 'NCT06040112', 'briefTitle': 'Effect of Atelocollagen Injection in Patients With Calcific Tendinitis', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effect of Atelocollagen Injection in Patients With Calcific Tendinitis', 'orgStudyIdInfo': {'id': 'PC23DISV0050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atelocollagen injection group', 'description': 'Atelocollagen injection', 'interventionNames': ['Device: Atelocollagen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lidocain injection group', 'description': 'Lidocain injection', 'interventionNames': ['Device: Atelocollagen']}], 'interventions': [{'name': 'Atelocollagen', 'type': 'DEVICE', 'otherNames': ['Tendoregen'], 'description': 'Tendoregen (Atelocollagen) injection', 'armGroupLabels': ['Atelocollagen injection group', 'Lidocain injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03341', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyungsuk Kim, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'tupacjr@daum.net', 'phone': '01074471541'}], 'facility': "Eunpyeong St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyungsuk Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hyungsuk Kim', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}