Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PulseNmore
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Human Factoring Validation of Pulsenmore ES Device
