Skip to main content
OpenTrials
Completed

NCT Number: NCT04399408

Instinct™ Ultrasound Device 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ultrasonography, Prenatal

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obstetrics Ultrasound (non invasive)

Device

Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.

Primary outcomes

  1. Safety - Device related SAE's

    Time frame: 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 outcomes

  1. User experience level

    Time frame: 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)

  2. Usability rating

    Time frame: 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)

  3. Device Sensitivity level

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

PulseNmore

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2020
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.