Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT01696305
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2012-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of normal esophageal transit in marshmallow esophagography', 'timeFrame': '6 Weeks after intervention'}], 'secondaryOutcomes': [{'measure': 'Adhesion severity using VAS', 'timeFrame': 'Baseline and 1, 6 and 12 weeks'}, {'measure': 'Swallow impairment', 'timeFrame': 'Baseline and 1, 6 and 12 weeks'}, {'measure': 'Voice impairment', 'timeFrame': 'Baseline and 1, 6 and 12 weeks'}, {'measure': 'voice behavior using Voice Range Profile (VRP) assessment', 'timeFrame': 'Baseline and 1, 6 and 12 weeks'}, {'measure': 'Injury of recurrent laryngeal nerve', 'timeFrame': 'Baseline and 1, 6 and 12 weeks'}, {'measure': 'Postoperative Sore Throat within 24hours after thyroidectomy', 'timeFrame': 'Pre- and Post (0, 24h)-opreation'}, {'measure': 'Adverse Events', 'timeFrame': 'during 12 weeks after investigational device use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thyroid disease', 'Hyalobarrier', 'Thyroidectomy', 'anti-adhesive effect'], 'conditions': ['Thyroid Disease']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).\n\nAn eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.\n\nDuring the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.\n\nNon-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female between 18 and 79 years of age\n* Patients diagnosed with thyroid disease who will undergo total thyroidectomy\n* Naive patients to thyroid surgery\n* Given written informed consent\n* Childbearing potential female patients who give the consent for contraception during the study\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding female patients\n* Abnormal coagulation panel test\n* Clinically abnormal laboratory values\n* Inappropriate general health conditions\n* Past or current medication history for hyperthyroidism\n* Medication with aspirin (or anti-platelet) before surgery\n* Current medication with anticoagulants\n* Inoperable (thyroidectomy) concurrent diseases\n* Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes\n* Participating in other interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT01696305', 'briefTitle': 'Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy', 'orgStudyIdInfo': {'id': 'Hyalobarrier_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyalobarrier', 'description': 'ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml\\*10ml/syringe and 5cm-cannula', 'interventionNames': ['Device: Hyalobarrier']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Guardix-SG', 'description': 'Poloxamer/sodium alginate mixture 6g/syringe', 'interventionNames': ['Device: Guardix-SG']}], 'interventions': [{'name': 'Hyalobarrier', 'type': 'DEVICE', 'armGroupLabels': ['Hyalobarrier']}, {'name': 'Guardix-SG', 'type': 'DEVICE', 'armGroupLabels': ['Guardix-SG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hoon Yub Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Jae-Bok Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Kyoung Sik Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}