NCT04399408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 10, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2020

Completed
Last Updated

April 26, 2023

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 10, 2020

Last Update Submit

April 25, 2023

Conditions

Ultrasonography, Prenatal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • User experience level

    Through study completion, an average of 1 year

  • Usability rating

    Through study completion, an average of 1 year

  • Device Sensitivity level

    Through study completion, an average of 1 year

Study Arms (1)

Study group

EXPERIMENTAL

Device users

Device: Obstetrics Ultrasound (non invasive)

Interventions

Obstetrics Ultrasound (non invasive)DEVICE

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

Study group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18.
  • Pregnancy week - 14-40.
  • Fetus - single, no known genetic or anatomic defects.
  • Able to understand and give informed consent.

You may not qualify if:

  • Multiple pregnancy.
  • Known genetic or anatomic defect to the fetus.
  • Inability to understand how to operate the device or give informed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Study Officials

  • Eran Hadar, M.D.

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 22, 2020

Study Start

May 6, 2019

Primary Completion

May 20, 2020

Study Completion

July 25, 2020

Last Updated

April 26, 2023

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)