An interventional study of Pulsenmore ES home ultrasound device in Perinatal Care, sponsored by PulseNmore. Completed at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by PulseNmore · Not applicable, Interventional, and Other
This is a multicenter, prospective, investigational device study designed to evaluate:
The safety, feasibility, and accuracy of the device, when used by pregnant individuals
PulseNmore is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single Arm home ultrasound in pregnant women users
Device: Pulsenmore ES home ultrasound device
Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week 14-38 of pregnancy
Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to assess fetal presentation from device derived input will be compared to the ground truth
Whether fetal presentation could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to assess placental location from device derived input will be compared to the ground truth
Whether placental location could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal movement from device derived input will be compared to the ground truth
Whether fetal movement could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal breathing from device derived input will be compared to the ground truth
Whether fetal breathing could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Time frame: Test to be conducted during week >27-38 of pregnancy
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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