Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-05 @ 5:39 PM
Study NCT ID:
NCT05885568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Transport of Biological Material by Drone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of destination arrival between both transportation types', 'timeFrame': 'one hour', 'description': 'Arrival of the load at its destination'}, {'measure': 'Variation of sample temperature during transportation', 'timeFrame': 'one hour', 'description': 'maintaining the defined temperatures'}, {'measure': 'Variation of sample allotted time after both transportation types', 'timeFrame': 'one hour', 'description': 'Absence of variation of the allotted time of both samples after transportation'}, {'measure': 'Variation of sample degradation after both transportation types', 'timeFrame': 'one hour', 'description': 'Absence of physical degradation of both samples after transportation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drone transport', 'biological samples', 'unmanned aerial system', 'UAS'], 'conditions': ['Drone Transport', 'Biological Samples', 'Unmanned Aerial System']}, 'descriptionModule': {'briefSummary': 'The Hospital Group of Territory Somme Littoral Sud, through its biology sector and in partnership with the company DELIVRONE, aims to engage in the experiment of transporting biological samples by means of a drone platform. Transport by air will be between the CHAM, the Abbeville Hospital and the CHU Amiens-Picardie by flying as much as possible over the waterways via the Somme. With a flight speed of around 100km/h at an altitude between 80 and 120 m, drones will be able to connect sites in less than an hour by transporting packages between 2 and 3 kg. Powered by propellers connected to rechargeable batteries, these drones do not emit CO2. This type of transport has not been validated in France by measuring the analytical impact of transport constraints for medical biology, and has never been evaluated according to the criteria of ISO 15189 standard allowing the certification of medical biology laboratories. Validation steps of this transportation method are therefore necessary on pathological samples prior to routine use.\n\nThe aim of the project is to validate the transport of biological samples by drone under defined flight conditions between CHAM and CHU Amiens-Picardie'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants of legal age\n* No contraindication to blood collection\n* Voluntary\n* informed and consenting participants\n\nExclusion Criteria:\n\n* Impossible to collect sufficient blood volume\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT05885568', 'acronym': 'TRANS-AIRGHT', 'briefTitle': 'Validation of the Transport of Biological Material by Drone', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Validation of the Conditions of Transport of Biological Material by Drone Within the "Groupement Hospitalier de Territoire Somme Littoral Sud"', 'orgStudyIdInfo': {'id': 'PI2023_843_0031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'car transportation', 'description': 'blood sample tube will be transported by courier (reference treatment)', 'interventionNames': ['Biological: blood sampling', 'Other: car transportation']}, {'type': 'EXPERIMENTAL', 'label': 'drone transportation', 'description': 'blood sample tube will be prepared for transport by drone (departure from CHAM, 1 hour flight, arrival at CHUAP)', 'interventionNames': ['Biological: blood sampling', 'Other: drone transportation']}], 'interventions': [{'name': 'blood sampling', 'type': 'BIOLOGICAL', 'description': 'Blood sampling from healthy volunteers', 'armGroupLabels': ['car transportation', 'drone transportation']}, {'name': 'drone transportation', 'type': 'OTHER', 'description': 'drone transportation', 'armGroupLabels': ['drone transportation']}, {'name': 'car transportation', 'type': 'OTHER', 'description': 'car transportation', 'armGroupLabels': ['car transportation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre Hospitalier de l'Arrondissement de Montreuil-sur-mer", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}