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Video guided for Pregnancy

N/A
Waitlist Available
Led By Susan Dallabrida
Research Sponsored by PulseNmore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights

Summary

The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety issues while using Pulsenmore ES device
User error while using Pulsenmore ES device

Trial Design

2Treatment groups
Experimental Treatment
Group I: Video guidedExperimental Treatment1 Intervention
Participants will perform a scan using Pulsenmore ES device in the video mode independently following video tutorial. Participants will be remotely observed during the scan and interviewed by a human factoring researcher right after
Group II: Clinician guidedExperimental Treatment1 Intervention
Participants will perform a scan using Pulsenmore ES device either in the clinician guided mode, guided by a health care professional via a telehealth visit. Participants and healthcare professionals will be remotely observed during the scan and interviewed by a human factoring researcher right after
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulsenmore ES home ultrasound
2023
N/A
~60

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Who is running the clinical trial?

PulseNmoreLead Sponsor
4 Previous Clinical Trials
433 Total Patients Enrolled
Susan DallabridaPrincipal InvestigatorSPRIM PRO
~22 spots leftby Sep 2025
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