Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal

NACompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

November 29, 2023

Primary Completion Date

August 30, 2024

Study Completion Date

June 19, 2025

Conditions
Pregnancy Related
Interventions
DEVICE

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."

Trial Locations (2)

Unknown

Poste de Santé de Karang, Karang

Centre de Santé de Sokone, Sokone

All Listed Sponsors
collaborator

Institut Pasteur de Dakar

OTHER

collaborator

Fondation Sanofi Espoir

UNKNOWN

lead

echOpen Factory

INDUSTRY

NCT05765539 - Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal | Biotech Hunter | Biotech Hunter