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Clinical Trials/CTRI/2020/09/027986
CTRI/2020/09/027986
Not yet recruiting
未知

Prospective ultrasound data collection of normal and abnormal obstetric and gynecological cases to develop an artificial intelligence algorithm - NI

Philips India Ltd0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Philips India Ltd
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Philips India Ltd

Eligibility Criteria

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 investigatorâ??s discretion).
  • •4\.Subject with neurological or psychiatric disorders or other disorders that affect the subjectâ??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

Not specified

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