Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-25 @ 7:12 PM
Study NCT ID:
NCT05415059
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEAFix Adhesion in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adhesion after 24 hours', 'timeFrame': '24 hours', 'description': 'Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)'}], 'secondaryOutcomes': [{'measure': 'Skin outcomes', 'timeFrame': '7 days', 'description': 'Asses for any issues with adhesion to the skin with a questionnaire on day 7 - likehart scale for different skin parameters ie. degree of itchiness with 0 being none and 3 being severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adhesion']}, 'descriptionModule': {'briefSummary': 'This study compares the adhesiveness of the 3M material to be used in the final design.', 'detailedDescription': 'The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.\n\nParticipants will also be assessed and followed up for any adverse skin issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Not been in a trial in last 12 weeks\n* mild to no skin issues\n\nExclusion Criteria:\n\n* any significant allergies\n* any allergies to skin adhesive\n* any medium to severe skin issues'}, 'identificationModule': {'nctId': 'NCT05415059', 'briefTitle': 'LEAFix Adhesion in Healthy Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Liverpool University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol', 'orgStudyIdInfo': {'id': 'SP0935'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Main Cohort', 'description': 'Cohort of healthy volunteers to have device affixed', 'interventionNames': ['Device: Covatech Stoma bag material']}], 'interventions': [{'name': 'Covatech Stoma bag material', 'type': 'DEVICE', 'description': 'Strips of Covatech Stoma bag used to asses adhesion of 3M material to be used in LEAFix device', 'armGroupLabels': ['Main Cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For internal use'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool University Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}