224
Participants
Start Date
November 29, 2023
Primary Completion Date
August 30, 2024
Study Completion Date
June 19, 2025
echOpen O1 Handheld Ultrasound device
"The performance of the Handheld ultrasound device (echOpen O1 device) will be assessed during these visits for all evaluation criteria.~* One examination with the US machine by the midwife focused on 4 targets ;~* One examination with a classic US machine by the same midwife (comparator) including the search for the four targets ;~* One examination with the US machine by a second operator ; Review of the images obtained by the US machine by the referring radiologist at a separate point of time.~The mode of delivery and the vital status of the mother and newborn will also be collected.~Operator A will start by using either the echOpen O1 device or the US machine (random order, via sealed envelopes) and will then perform the other type of examination.~Another operator (Operator B) will come to perform an examination with the Handheld ultrasound device (blind to the result of the first operator).~The switch between operators A and B will also be random."
Poste de Santé de Karang, Karang
Centre de Santé de Sokone, Sokone
Institut Pasteur de Dakar
OTHER
Fondation Sanofi Espoir
UNKNOWN
echOpen Factory
INDUSTRY