Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06123104
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Automatic Tourniquets for Soldiers During Wartime
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to distal limb arterial occlusion as assessed by Doppler', 'timeFrame': '60 seconds', 'description': 'Time to distal limb arterial occlusion as assessed by Doppler is recorded'}], 'secondaryOutcomes': [{'measure': 'Safety of using automatic tourniquets', 'timeFrame': 'Will be assessed via questionnaire up to 5 minutes following the intervention.', 'description': 'Safety issues, specifically peripheral limb numbness will be assessed via questionnaire. Scale is from 0 to 5, 0 is "No numbness", 5 is "Severe numbness"'}, {'measure': 'Usability of using automatic tourniquets', 'timeFrame': 'Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.', 'description': 'Usability of using automatic tourniquets will be assessed via questionnaire up to 5 minutes following the intervention. Scale for ease to secure the tourniquet is from 0 to 5, 0 is "Very difficult to secure", 5 is "Very easy to secure"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma Injury', 'Hemorrhage Wound']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:\n\n* Are AUTs effective in occlusion of blood flow\n* Are AUTs easy to use\n\nParticipants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).\n\nFollowing each application, the following parameters will be assessed:\n\n1. Limb blood flow\n2. Ease of use\n\nResearchers will compare the results of the AUT and CAT to see if AUT is as effective as CAT in blood occlusion, and if AUT is easy to use as the CAT.', 'detailedDescription': 'The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:\n\n* Are AUTs effective in occlusion of blood flow\n* Are AUTs easy to use\n\nParticipants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Soldier in active service or active reserve service.\n\nExclusion Criteria:\n\n* Muscle disorders\n* Peripheral nerve disorders\n* Skin diseases of the limbs\n* Limb surgery in the past\n* Rickets\n* Hypertension'}, 'identificationModule': {'nctId': 'NCT06123104', 'briefTitle': 'Assessment of Automatic Tourniquets for Soldiers During Wartime', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development', 'orgStudyIdInfo': {'id': '1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automatic Tourniquet', 'description': 'Automatic pneumatic tourniquet', 'interventionNames': ['Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combat Application Tourniquet (CAT)', 'description': 'Combat Application Tourniquet Generation 7', 'interventionNames': ['Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)']}], 'interventions': [{'name': 'Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)', 'type': 'DEVICE', 'description': 'Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds', 'armGroupLabels': ['Automatic Tourniquet', 'Combat Application Tourniquet (CAT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tomer Erlich, MD', 'role': 'CONTACT', 'email': 'tomer.erlich@gmail.com', 'phone': '+972-3-737-9506'}], 'facility': 'Tel hashomer', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Tomer Erlich, MD', 'role': 'CONTACT', 'email': 'tomer.erlich@gmail.com', 'phone': '+972-3-737-9506'}], 'overallOfficials': [{'name': 'Tomer Erlich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Medical innovation and R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Innovation, R&D Directorate, IDF Medical Corps Head of Medical Research, Directorate of Defense R&D, Israeli Ministry of Defense (IMOD DDR&D)', 'investigatorFullName': 'TOMER ERLICH', 'investigatorAffiliation': 'Medical Corps, Israel Defense Force'}}}}