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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1
Rabin Medical Center
Petah Tikva, Israel, 49100