Instinct™ Ultrasound Device Safety, Efficacy and Usability

Ultrasonography, Prenatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399408
• Other study ID #: 0004-19-RMC
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: July 25, 2020

Study information

• Verified date: May 2020
• Source: PulseNmore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 25, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ultrasonography, Prenatal

Intervention

Device:
• Obstetrics Ultrasound (non invasive)
Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
PulseNmore

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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