Status:

COMPLETED

Instinct™ Ultrasound Device Safety, Efficacy and Usability

Lead Sponsor:

PulseNmore

Conditions:

Ultrasonography, Prenatal

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attache...

Detailed Description

Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or g...

Eligibility Criteria

Inclusion

  • Age ≥ 18.
  • Pregnancy week - 14-40.
  • Fetus - single, no known genetic or anatomic defects.
  • Able to understand and give informed consent.

Exclusion

  • Multiple pregnancy.
  • Known genetic or anatomic defect to the fetus.
  • Inability to understand how to operate the device or give informed

Key Trial Info

Start Date :

May 6 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 25 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04399408

Start Date

May 6 2019

End Date

July 25 2020

Last Update

April 26 2023

Active Locations (1)

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Rabin Medical Center

Petah Tikva, Israel, 49100