Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:13 AM
Study NCT ID:
NCT06878794
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-17
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MOCART score', 'timeFrame': 'Baseline (Before treatment), 6 and 12 months after treatment'}, {'measure': 'Lysholm score', 'timeFrame': 'Baseline (Before treatment), 3、 6 and 12 months after treatment'}, {'measure': 'IKDC score', 'timeFrame': 'Baseline (Before treatment), 3、 6 and 12 months after treatment'}], 'secondaryOutcomes': [{'measure': 'T2 mapping', 'timeFrame': 'Baseline (Before treatment),12 months after treatment'}, {'measure': 'Equipment use and evaluation', 'timeFrame': 'During operation'}, {'measure': 'The occurrence of adverse events related to the test device', 'timeFrame': '12 months after treatment'}, {'measure': 'The incidence of device related SAE requiring further surgical intervention within 12 months after surgical', 'timeFrame': '12 months after treatment'}, {'measure': 'Equipment defect incidence rate', 'timeFrame': 'During operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meniscus tear'], 'conditions': ['Unilateral Meniscus Tear of the Knee Joint']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. The patient is aged between 18 and 60 years old (including 18 and 60 years old), regardless of gender; 2. Unilateral meniscus tear of the knee joint; 3. Normal joint range of motion; 4. The subjects agree to participate in this trial and sign the "Subject Informed Consent Form".\n\nExclusion Criteria:\n\n* 1\\. Body mass index BMI\\>32 kg/m2 (BMI=weight divided by height squared); 2. Patients with abnormal lower limb force lines that require correction; 3. Patients with multiple ligament injuries or complete meniscectomy; 4. Individuals with a history of allergies to biological glue as the chief complaint; 5. Patients with more than 2 or extensive cartilage defects in a single knee joint, and patients with bilateral knee joint cartilage defects; 6. Those who have undergone open knee surgery within the past 6 months; 7. Pregnant or lactating women, or those who plan to conceive during the trial period, and those whose blood HCG test results are positive before the trial; 8. Patients with infectious, immune, or metabolic arthritis in the knee joint; 9. Patients who participated in any other clinical trial or did not reach the trial endpoint within the first 3 months prior to enrollment; 10. Other circumstances determined by the researcher to be unsuitable for inclusion in this study.'}, 'identificationModule': {'nctId': 'NCT06878794', 'briefTitle': 'IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears', 'organization': {'class': 'NETWORK', 'fullName': 'First Affiliated Hospital of Ningbo University'}, 'officialTitle': 'IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears', 'orgStudyIdInfo': {'id': '2024-R049-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Using the meniscus suture system', 'interventionNames': ['Procedure: Using the meniscus suture system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'Using medical biological glue for filling And Using the meniscus suture system', 'interventionNames': ['Combination Product: Using medical biological glue for filling And Using the meniscus suture system']}], 'interventions': [{'name': 'Using medical biological glue for filling And Using the meniscus suture system', 'type': 'COMBINATION_PRODUCT', 'description': 'Using medical biological glue for filling And Using the meniscus suture system', 'armGroupLabels': ['Experimental group']}, {'name': 'Using the meniscus suture system', 'type': 'PROCEDURE', 'description': 'Using the meniscus suture system', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'overallOfficials': [{'name': 'Jiang Zhu', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Ningbo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Ningbo University', 'class': 'NETWORK'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Xinxiang Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}