Fetal Heart Ultrasound Imaging – Prospective data collection of normal and abnormal cases
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- 100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study.
Study Overview
Brief Summary
| This study is a prospective data collection study. |
The main objective of the study is to collect DICOM ultrasound imaging data in 200 fetuses with normal or abnormal fetal heart to design and develop algorithms for automated/semi-automated fetal heart ultrasound assessment.
The data collection will be done at two independent clinical sites with non-competitive recruitment (100 subjects total at each centre including 10 abnormal fetal hearts). Both centres: Mediscan systems, Chennai and Thane Ultrasound centre, Mumbai, are referral diagnostic ultrasound centres in India.
Data collection will be done on the commercial registered ultrasound devices of the centre (Philips Affiniti 70, Philips Epiq 5 or 7) and one commercially released ultrasound device from the sponsor (Philips Affiniti 70 at Mediscan systems only) and will be used within the intended use.
The end-point of the study will be reached when the data from the 200 ultrasound scans has been collected and transferred to the Sponsor after de-identification.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female patients, aged 18 years or more, presenting for a routine or referred US scan with: A pregnancy equal or above 17 weeks of gestation Singleton pregnancy or multiple pregnancy Normal pregnancy or abnormal pregnancy (maternal or fetal conditions) Willing and able to provide informed consent.
Exclusion Criteria
- •Subject aged below 18 years.
- •Subject with a pregnancy younger than 17 weeks.
- •Subjects (mothers) presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigator’s discretion).
- •Subject (mother) with neurological or psychiatric disorders or other disorders that affect the subject’s understanding of the information provided with the consent form.
- •Subject unwilling or unable to provide informed consent.
Outcomes
Primary Outcomes
100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study.
Time Frame: Estimated completion date: 28th February 2019
Secondary Outcomes
No secondary outcomes reported