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Instinct™ Ultrasound Device Safety, Efficacy and Usability

NCT04399408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-04-26

No results posted yet for this study

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.

Conditions

  • Ultrasonography, Prenatal

Interventions

DEVICE

Obstetrics Ultrasound (non invasive)

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

Sponsors & Collaborators

  • PulseNmore

    lead INDUSTRY

Principal Investigators

  • Eran Hadar, M.D. · Rabin Medical Center

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2020-05-20
Completion
2020-07-25

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399408 on ClinicalTrials.gov