Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-09 @ 5:28 AM
Study NCT ID:
NCT01895933
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adhesion Rate', 'timeFrame': 'at 2 weeks', 'description': 'Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)'}], 'secondaryOutcomes': [{'measure': 'Adhesion Rate', 'timeFrame': 'at 1 and 4 weeks', 'description': 'Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Investigational device (chitosan gel)', 'Wound healing', 'Endoscopic sinus surgery', 'SurgiShield'], 'conditions': ['Wound Healing']}, 'descriptionModule': {'briefSummary': 'This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 21 years of age\n* both side sinusitis\n* will undergo endoscopic sinus surgery\n* volunteers with informed consent and signature\n\nExclusion Criteria:\n\n* suppressed immunity patient\n* systemic grave condition\n* pregnant\n* cancer\n* severe disease patients\n* asthma patients\n* AIDS\n* cystic fibrosis\n* ciliary immobility syndrome\n* neutropenia neutrophil\n* immunoglobulin deficiency\n* wound healing immune disease\n* severe liver disease\n* severe kidney disease\n* lymph or blood clotting disorder or patients treated with coagulants\n* patients taking oral or parenteral glucose for diabetes thrombocytopenia\n* infectious disease\n* currently lactating\n* severe septal deviation\n* case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)\n* shellfish allergy\n* food allergy\n* had endoscopic sinus surgery in the past\n* patient with large sinus polyps\n* patients who have received treatment for extrasinus complication'}, 'identificationModule': {'nctId': 'NCT01895933', 'briefTitle': 'Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'D.med'}, 'officialTitle': 'The Aim of This Study is to Evaluate the Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel Made by D Med', 'orgStudyIdInfo': {'id': 'DMED-SS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active / control', 'description': 'One side has been treated with SurgiShield', 'interventionNames': ['Device: 5ml surgishield']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'One side has no intervention'}], 'interventions': [{'name': '5ml surgishield', 'type': 'DEVICE', 'description': 'in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site\n\nmerocel in the inflated state maintained for 36\\~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site', 'armGroupLabels': ['Active / control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chungju', 'state': 'ChoongChungBukDo', 'country': 'South Korea', 'facility': 'Chungbook National University Hospital', 'geoPoint': {'lat': 36.97666, 'lon': 127.9287}}, {'zip': '31116', 'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'D.med', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dankook University', 'class': 'OTHER'}, {'name': 'Chungbuk National University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}