NCT04399408|Completed
Instinct™ Ultrasound Device Safety, Efficacy and Usability
Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
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Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 6, 2019
Actual (reported)Primary Completion
May 20, 2020
Actual (reported)Study Completion
July 25, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 25, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2019
Actual (reported)May 10, 2020
Actual (reported)May 20, 2020
Actual (reported)May 22, 2020
Actual (reported)July 25, 2020
Actual (reported)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
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
Device users
Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rabin Medical Center
Petah Tikva, 49100, Israel
Eran Hadar, M.D.
Rabin Medical Center
100 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2020
First Posted
May 22, 2020
Study Start
May 6, 2019
Actual (reported)Assesment by Ultrasonography of the Perineal-cephalic Distance
Contact the study team to confirm eligibility.
Primary Completion
May 20, 2020
Actual (reported)Study Completion
July 25, 2020
Actual (reported)Last Updated
April 26, 2023
Record last verified: 2020-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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