Validation of the Transport of Biological Material by Drone (TRANS-AIRGHT)

May 22, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • Recruiting
        • CHU Amiens Picardie
        • Contact:
        • Principal Investigator:
          • Mohamed MENOUAR, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Biological: blood sampling
Blood sampling from healthy volunteers
Other: car transportation
car transportation
Experimental: drone transportation
blood sample tube will be prepared for transport by drone (departure from CHAM, 1 hour flight, arrival at CHUAP)
Biological: blood sampling
Blood sampling from healthy volunteers
Other: drone transportation
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Centre Hospitalier de l'Arrondissement de Montreuil-sur-mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2023_843_0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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