Instinct™ Ultrasound Device Safety, Efficacy and Usability

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography, Prenatal
• Intervention / Treatment: Device: Obstetrics Ultrasound (non invasive)

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 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah tikva, Israel, 49100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PulseNmore
• Investigators: Principal Investigator: Eran Hadar, M.D., Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): July 25, 2020

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0004-19-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No