Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-01 @ 2:09 AM
Study NCT ID:
NCT06369233
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI scar score', 'timeFrame': 'At 12 weeks after surgery', 'description': 'Primary effectiveness endpoint (0\\~4, low Scar score through MRI means better)'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index(ODI) score', 'timeFrame': 'Before surgery, At 2, 12 weeks after surgery', 'description': 'Secondary effectiveness endpoint (0\\~50, low ODI score means better)'}, {'measure': 'Visual Analog Scale(VAS) Back & Leg Pain Score', 'timeFrame': 'Before surgery, At 2, 12 weeks after surgery', 'description': 'Secondary effectiveness endpoint (0\\~100, low VAS score means better)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disc herniation', 'laminectomy', 'anti-adhesion', 'disc resection', 'MegaShield', 'MegaShield-SP'], 'conditions': ['Herniation, Disc']}, 'descriptionModule': {'briefSummary': 'This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.', 'detailedDescription': 'To evaluate preventing adhesion, the study group is compared with MegaShield®-SP or Guardix-SP Plus after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess Questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 20 to 70 years.\n* Patient diagnosed with single-level lumbar disc herniation and scheduled to perform Lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy.\n* Patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form.\n\nExclusion Criteria:\n\n* Patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(FLLDH).\n* Patient diagnosed with spinal cord disease\n* Patient who needs spinal fusion\n* Patient who has previous experience in spinal surgery\n* Patient diagnosed with a serious liver or kidney disease\n* Patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents\n* Patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment,\n* Patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease\n* Patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery\n* Patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours\n* Patients who participated in other clinical trials within 30 days from the date of screening\n* Patients who are unable to take MRI scans\n* Pregnant or lactating women\n* Patients who are not eligible for clinical trials according to the investigator's judgement\n* Patients with a history of hypersensitivity to the main and other components of the investigational device\n* Patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device"}, 'identificationModule': {'nctId': 'NCT06369233', 'briefTitle': 'Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'L&C Bio'}, 'officialTitle': 'Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery: A Multicenter, Randomized, Subjects-independent Evaluator Blinded, Active-control Comparative, Non-inferior, Prospective Confirmatory Clinical Study', 'orgStudyIdInfo': {'id': 'LNC-MS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MegaShield®-SP', 'description': 'The study group is applied with MegaShield®-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.', 'interventionNames': ['Device: MegaShield®-SP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Guardix-SP Plus', 'description': 'The study group is applied with Guardix-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.', 'interventionNames': ['Device: Guardix-SP Plus']}], 'interventions': [{'name': 'MegaShield®-SP', 'type': 'DEVICE', 'description': 'MegaShield®-SP application Lumbar discectomy or laminectomy', 'armGroupLabels': ['MegaShield®-SP']}, {'name': 'Guardix-SP Plus', 'type': 'DEVICE', 'description': 'Guardix-SP Plus application Lumbar discectomy or laminectomy', 'armGroupLabels': ['Guardix-SP Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03312', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'HyungYul Park', 'role': 'CONTACT', 'email': 'matrixbest@naver.com', 'phone': '02-2030-4536'}, {'name': 'HyungYul Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Eunpyeong ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Siyoung Park', 'role': 'CONTACT', 'email': 'drspine90@yuhs.ac', 'phone': '2228-2194'}, {'name': 'Siyoung Park, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jiwon Kwon', 'role': 'CONTACT', 'email': 'KWONJJANNG@yuhs.ac', 'phone': '2019-3411'}, {'name': 'Jiwon Kwon, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '13620', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hojung Kim', 'role': 'CONTACT', 'email': 'oshjkim@gmail.com', 'phone': '031-787-7202'}, {'name': 'Hojung Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bundang Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'So young Kim', 'role': 'CONTACT', 'email': '1462017@lncbio.co.kr', 'phone': '+82 070-7791-8940'}, {'name': 'Siyoung Park', 'role': 'CONTACT', 'email': 'drspine90@yuhs.ac'}], 'overallOfficials': [{'name': 'Siyoung Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University College of Medicine, Severance Hospital'}, {'name': 'Jiwon Kwon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University College of Medicine Gangnam severance Hospital'}, {'name': 'Hojung Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'HyungYul Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Eunpyeong St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'L&C Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}