Human Factoring Validation of Pulsenmore ES Device

NCT06567067 | Completed FDA Device

• 1 other identifier: SPRIM 22-1200
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Safety issues while using Pulsenmore ES device

  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

  Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment

  One day

Study Arms (2)

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

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

Interventions

Pulsenmore ES home ultrasound DEVICE

Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched

Clinician guided; Video guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• PulseNmore: lead

Study Sites (2)

Center for Fetal Medicine and Women Ultrasound

Los Angeles, California, 90404, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Susan Dallabrida

  SPRIM PRO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 22, 2024
• Study Start: February 9, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (2)