- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885568
Validation of the Transport of Biological Material by Drone (TRANS-AIRGHT)
Validation of the Conditions of Transport of Biological Material by Drone Within the "Groupement Hospitalier de Territoire Somme Littoral Sud"
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.
The aim of the project is to validate the transport of biological samples by drone under defined flight conditions between CHAM and CHU Amiens-Picardie
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Baptiste Demey, Pharm D03 22 08 70 65
- Phone Number: 03 22 08 70 65
- Email: demey.baptiste@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Baptiste Demey, Pharm D
- Phone Number: 03 22 08 70 65
- Email: demey.baptiste@chu-amiens.fr
-
Principal Investigator:
- Mohamed MENOUAR, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants of legal age
- No contraindication to blood collection
- Voluntary
- informed and consenting participants
Exclusion Criteria:
- Impossible to collect sufficient blood volume
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: car transportation
blood sample tube will be transported by courier (reference treatment)
|
Blood sampling from healthy volunteers
car transportation
|
Experimental: drone transportation
blood sample tube will be prepared for transport by drone (departure from CHAM, 1 hour flight, arrival at CHUAP)
|
Blood sampling from healthy volunteers
drone transportation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of destination arrival between both transportation types
Time Frame: one hour
|
Arrival of the load at its destination
|
one hour
|
Variation of sample temperature during transportation
Time Frame: one hour
|
maintaining the defined temperatures
|
one hour
|
Variation of sample allotted time after both transportation types
Time Frame: one hour
|
Absence of variation of the allotted time of both samples after transportation
|
one hour
|
Variation of sample degradation after both transportation types
Time Frame: one hour
|
Absence of physical degradation of both samples after transportation
|
one hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI2023_843_0031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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