Prospective ultrasound data collection of normal and abnormal obstetric and gynecological cases to develop an artificial intelligence algorithm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- This is a data collection study, there are no specific primary clinical outcome other than collecting the ultrasound data as per the clinical
Study Overview
Brief Summary
Thisstudy is a prospective data collection study.
The main objective of the study is to collect2D, M-mode and 3D ultrasound imaging in the early first trimester pregnancies(5 weeks to 10 weeks and 6 days) and in gynaecological subjects to check thefeasibility of automated detection and quantification in early normal andabnormal pregnancies. In order to build clinically useful algorithms, the datashould represent a variety of situations that is found in current practice; thedataset should hence contained at least the following:
· Firsttrimester pregnancies (normal and abnormal such as ectopic pregnancies)
· Surroundinganatomical structures (such as ovaries, Fallopian tubes and Douglas cul-de-sac)
· Imagingdata with features that can be confused with early pregnancy (such as normaland abnormal uterine findings in non-pregnant women)
· Imagesacquired with different ultrasound modes: standard 2D view, M-mode (fetal heartrate), 3D.
Thedata collection study will be performed at Gunasheela Surgical and MaternityHospital, Gunasheela IVF centre, Bangalore (site 1) and Thane Ultrasoundcentre, Mumbai (site 2), both are referral centres in India.
De-identified2D, 3D ultrasound images and videos of 250 women presenting with: normal first trimester pregnancies(180), abnormal first trimester pregnancies (30), normal (20) or abnormal (20)pelvic scan will be shared with the sponsor (125 subjects total per site).
Datacollection will be done on the commercial registered ultrasound devices of thecentres (Philips Affiniti 50/70, Philips Epiq 5/7) and on a commerciallyreleased ultrasound device from the sponsor (ClearVue 650/850). All deviceswill be used within their intended use.
Studywill be registered in the CTRI website as per local regulations (India).
The variety and number of data/image sets neededto build accurate machine learning algorithms is high and an amendment will beproposed if the data sets do not meet the researchers’ requirement to buildaccurate algorithms as decided by the researchers or after review ofalgorithms’ results by clinicians/KOLs (interviews/focus group, etc…
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Inclusion criteria for subject selection 1.Female patients, aged 18 years or more, presenting for a routine or referred obstetric or a gynaecological ultrasound scan 2.For obstetric cases only: a.An ultrasound gestational age between 5 to 10 weeks and 6 days of gestation for normal pregnancies b.A gestational age inferior to 14 weeks for abnormal pregnancies (ectopic pregnancy, blighted ovum and other types of pregnancy loss, hydatiform mole, etc.) c.Singleton pregnancy or multiple pregnancy d.Normal pregnancy or abnormal pregnancy (abnormal early first trimester conditions such as ectopic pregnancy, blighted ovum and other types of pregnancy loss, hydatiform mole, etc.) 3.For gynaecologic cases only: Subject presenting with a normal or abnormal pelvic scan 4.Subject willing and able to provide informed consent.
Exclusion Criteria
- •1.Subject aged below 18 years.
- •2.For obstetric cases only: a.Subject with a pregnancy younger than 5 and equal or older than 11 weeks for normal pregnancies.
- •b.Subject with a pregnancy superior to 14 weeks for abnormal pregnancies.
- •3.Subject presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigator’s discretion).
- •4.Subject with neurological or psychiatric disorders or other disorders that affect the subject’s understanding of the information provided with the consent form.
- •5.IIliterate subjets and subjects unwilling or unable to provide informed consent.
Outcomes
Primary Outcomes
This is a data collection study, there are no specific primary clinical outcome other than collecting the ultrasound data as per the clinical
Time Frame: 31st May 2021
Protocol. The primary endpoint of the study will be reached when
Time Frame: 31st May 2021
125 subjects with data validated by the Sponsor have been enrolled at each site.
Time Frame: 31st May 2021
Secondary Outcomes
- NA(NA)