Pregnancy RelatedNCT06567067
Human Factoring Validation of Pulsenmore ES Device
An observational study of Pregnancy Related, run by PulseNmore at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Pulsenmore ES home ultrasound
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2023to 21 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Center for Fetal Medicine and Women Ultrasound
Los Angeles, California, 90404
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- Pulsenmore ES home ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsenmore ES home ultrasoundDevice
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Pulsenmore ES home ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start9 Feb 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseNmore
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Dallabrida, Principal investigator, SPRIM PRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567067
- Sponsor's protocol ID
- SPRIM 22-1200
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy
- ClinicalTrials.gov ID
- NCT06567067
- Acronym / sponsor ID
- SPRIM 22-1200
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- PulseNmoreIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video guided | – | Device: Pulsenmore ES home ultrasoundParticipants 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 |
| Clinician guided | – | Device: Pulsenmore ES home ultrasoundParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsenmore ES home ultrasoundFetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched | Device | Clinician guided, Video guided |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Dallabrida principal investigator
SPRIM PRO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by PulseNmore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety issues while using Pulsenmore ES device (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.