Clinical Data Collection for Obstetric Ultrasound Algorithms

ConditionPregnancy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorCaption Health, Inc.

About this trial

The goal of this clinical trial is to

* Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites. * Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor

Consented participants will be asked to take part in a research ultrasound scan

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants aged 18 years or older at time of consent.

Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.

Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.

Participants who provide written consent.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Research Ultrasound scan
Device
Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Treatment groups

700 Participants

are divided into 2 treatment groups

Group A: Group 1: Pregnant SubjectsOther 1 intervention

Group B: Group 2- Non pregnant SubjectsOther 1 intervention

Trial outcomes

Primary outcomes

Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history

All the participant's research ultrasound image will be obtained. This image will be checked for image quality on various stages of pregnancy as well as for non pregnant subjects. These images will be used to develop algorithms for measuring gestational age, placenta location etc.

Time frame

9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Caption Health, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: