Instinct™ Ultrasound Device Safety, Efficacy and Usability

PulseNmore

Status: Completed

Conditions: Ultrasonography, Prenatal

Treatments: Device: Obstetrics Ultrasound (non invasive)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04399408

0004-19-RMC

Details and patient eligibility

About

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 attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.

Full 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 genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study group

Experimental group

Description:

Device users

Treatment:

Device: Obstetrics Ultrasound (non invasive)