Instinct™ Ultrasound Device Safety, Efficacy and Usability

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability

Conditions
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Ultrasonography, Prenatal

Intervention / Treatment
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* Device: Obstetrics Ultrasound (non invasive)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Device users | Device: Obstetrics Ultrasound (non invasive)<br>* Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Device related SAE's | The device will be deemed safe if all SAE will be classified as not device related | Through study completion until all subject gave birth, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User experience level | User experience will be defined positive if the mean value of all answers to user satisfaction related questions in the CRF is better or equal 3.5 out of 5. Questions will be graded by a visual analog scale with scores of 1 to 5 (1=very poor, 5=very high) | Through study completion, an average of 1 year | 
| Usability rating | Usability will be defined positive if the mean value of all answers to usability related questions in the CRF is better or equal 3.5 out of 5. Questions will be graded by a visual analog scale with scores of 1 to 5 (1=very poor, 5=very high) | Through study completion, an average of 1 year | 
| Device Sensitivity level | Medical data recorded by the device will be defined useful if: At least 70% of 3 out of 5 tested parameters (Fetal Heartbeat, Movements, Tone, Breathing and Amniotic fluids) were classified by professional evaluator as could be estimated. In more than 90% of scans, professional evaluator will be able to define Fetal Viability (identification of at least one of the following parameters: Fetal Heartbeat, Movements, Tone and Breathing) | Through study completion, an average of 1 year |