An interventional study of echOpen O1 Handheld Ultrasound device in Pregnancy Related, sponsored by echOpen Factory. Completed at 2 sites in Senegal. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by echOpen Factory · Not applicable, Interventional, and Diagnostic
Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. However, the pregnancy follow-up relies in part on the visual investigation by ultrasound scanners that estimate the risks of morbi-mortality for the mother and child during and after pregnancy. The WHO recommendations support at least one ultrasound before 24 weeks of amenorrhea. Thus, at the same time as a usual clinical examination, the possibility of visually assessing certain relevant criteria would help to increase the effectiveness of follow-up visits without complicating the care journey. A simple ultra-portable device would be an opportunity for caregivers to facilitate the detection of complications and thus offer a more adapted follow-up and orientation.
This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.
The echOpen O1 Ultrasound Probe is a medical device designed to guide the diagnosis during clinical examination by providing a non-invasive, non-irradiant inside body image.
The investigator's hypothesis is that the use of this ultrasound stethoscopy probe during pregnancy, by a trained midwife, would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, the investigators propose a pilot study to evaluate, under field conditions, the performance of the echOpen O1 probe as part of the 3rd-trimester pregnancy monitoring, compared to a standard ultrasound examination, routinely performed with an ultrasound machine.
The main objective of this prospective pilot study is to evaluate the performance and operationality of the echOpen O1 probe from the 37th week of amenorrhea.
The secondary objectives are :
To evaluate the feasibility and usability of the echOpen O1 probe in the context of pregnancy monitoring by midwives and in zone field conditions:
This is the only study on the registry with echOpen Factory as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks.
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.
Also known as: Multicentric prospective comparative study
The intra-operator agreement
The intra-operator agreement will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are: The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an intra-operator concordance, the images for the 4 ultrasound targets (collected by the same operator) must be identical for both devices (echOpen probe and Ultrasound device routinely used in pregnant women)
Time frame: Day 0
The inter-operator agreement
The inter-operator concordance will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are: The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an inter-operator concordance, the images on the 4 ultrasound targets (collected by two different operators) must be identical for the same device (echOpen probe). All ultrasound images will go to the radiologist for review and validation. This review will be done blindly of the result provided by the operators.
Time frame: Day 0
Plan to share: No
Ran from Nov 2023 to primary completion in Aug 2024, 9 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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