Instinct™ Ultrasound Device Safety, Efficacy and Usability

Not Applicable

Completed

• Conditions: Ultrasonography, Prenatal
• Interventions: Device: Obstetrics Ultrasound (non invasive)

• Registration Number: NCT04399408
• Lead Sponsor: PulseNmore

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

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 Timeline

• Study Start: 2019-05-06
• Status Verified: 2020-05
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-19
• Primary Completion: 2020-05-20
• Study First Posted: 2020-05-22
• Study Completion: 2020-07-25
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Obstetrics Ultrasound (non invasive)	Device users

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Device Sensitivity level	Through study completion, an average of 1 year	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)
Usability rating	Through study completion, an average of 1 year	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)
User experience level	Through study completion, an average of 1 year	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)

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel