Status:
COMPLETED
Human Factoring Validation of Pulsenmore ES Device
Lead Sponsor:
PulseNmore
Conditions:
Pregnancy Related
Eligibility:
All Genders
18+ years
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06567067
Start Date
February 9 2023
End Date
December 21 2023
Last Update
August 22 2024
Active Locations (2)
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1
Center for Fetal Medicine and Women Ultrasound
Los Angeles, California, United States, 90404
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115