Human Factoring Validation of Pulsenmore ES Device

August 19, 2024 updated by: PulseNmore

Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90404
        • Center for Fetal Medicine and Women Ultrasound
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The participants usability study will recruit singleton pregnant woman, gestational age (14-38 weeks) across al BMI groups and up to BMI 40.

The healthcare professional (HCP) usability study will include only the first time the HCP performs the clinician-guided session.

Description

Inclusion Criteria for participants:

  • The participant has voluntarily provided and signed the informed consent form (ICF)
  • The participant has voluntarily provided authorization and signed the Videography and Photography Release form
  • The participant is able to speak, read, write and comprehend US English and resides in the United States of America
  • The participant to have adequate communications skills
  • Pregnant women > 18 years of age
  • A singleton gestation
  • Gestational age between 14 to 38 weeks with a prior scan demonstrating fetal viability and confirming dates
  • Maximum BMI of 40
  • Willing and able to participate in a 60-75 min video and is willing to be audio recorded for the post-procedure interview

Inclusion criteria for HCP:

  • The HCP has voluntarily provided and signed the HCP consent information sheet (CIS)
  • The HCP has voluntarily provided authorization and signed the HCP Videography and photography Release form
  • The HCP is able to speak, read, write and comprehend US English and resides in the United States of America.
  • The HCP has adequate communications skills
  • The HCP is willing and able to participate in one 60 min video call and is willing to be audio recorded during the interview.

Exclusion Criteria for participants:

  • Multiple gestation
  • Skin problem(s) in the abdominal area (such as wounds, cuts in the skin and skin rash)
  • The participant has a visual or hearing impairment, and/or a condition that affects her motor and/or cognitive skills, that would prevent her from independently performing a fetal ultrasound scan at home
  • The participant has a language barrier that can affect the communication and compliance to the usability study requirement
  • Uncontrolled and untreated psychiatric conditions for a minimum of 6 months prior to screening,
  • Alcohol or drug dependence with current symptoms
  • Previous Pulsenmore ES trials and have previously used the Pulsenmore ES device
  • Known fetal and genetic anomalies.

Exclusion criteria for clinicians:

  • The HCP has a visual or hearing impairment, that would prevent him or her from independently directing a fetal ultrasound scan
  • The HCP has a language barrier and/or in the opinion of the recruiting interviewer provides any reason to believe that compliance with the study requirements will not be achievable
  • The HCP has participated in in previous Pulsenmore trials and have previously used the Pulsenmore ES device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Video guided
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
Device: Pulsenmore ES home ultrasound
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
Clinician guided
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
Device: Pulsenmore ES home ultrasound
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety issues while using Pulsenmore ES device
Time Frame: One day
Any safety issue, either serious that could cause serious injury or death to the user, or non serious
One day
User error while using Pulsenmore ES device
Time Frame: One day
Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PulseNmore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Dallabrida, SPRIM Pro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPRIM 22-1200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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