Portable UltrasoundNCT03486444
Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications
A study testing Phillips Lumify Diagnostic Ultrasound System and Surveys in people with Portable Ultrasound, run by University of Cincinnati at 1 site in United States.
Trial summary
This is a Phase I study to assess feasibility. There will be no impact on clinical care based on this study. The ultrasound system is FDA approved and could be used for clinical care independent of this research study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Portable Ultrasound
- What is being tested?
- Phillips Lumify Diagnostic Ultrasound System and Surveys
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects or patients greater than or equal to 18 years of age
- Patients who are capable of giving informed consent
Who cannot join
- Prisoners
- Participants incapable of giving informed consent, even if they have a power of healthcare attorney who is clearly identifiable and available for the consenting process.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
About this study
This is a Phase I study to assess feasibility. There will be no impact on clinical care based on this study. The ultrasound system is FDA approved and could be used for clinical care independent of this research study. When a subject receives an ultrasound examination as part of standard of care or within another clinical research trial, such an examination may serve for an intra-individual comparator examination between conventional and new, ultra-portable ultrasound imaging. Patients will be identified in the clinical setting when appropriate and will be appropriately approached for consent for a combination of ultrasound with the physical exam, for medical student education, IV access, and novel application. Patients will be enrolled and accounted for in the appropriate sub-population. Additionally, to understand the impact of ultraportable ultrasound, survey tools will be used to understand the workflow and clinical care applications and integration of these devices. All staff and student members will be appropriately consented; however, the investigators anticipate that this portion of the study will be minimal risk with online consent waivers. Finally, the volunteer population will allow us to practice the use of this equipment and understand the limitations and applicability. The results will be the images acquired as well as surveys from the volunteers and those performing the scans, who will be enrolled in the staff population of this study. No significant risk is identified for subjects in this study. The largest risk, although still minimal, is an incidental finding. For this study, subjects will have the choice if they would like to be informed of an incidental finding. Reporting of incidental findings will be conducted by designated study staff after appropriate consultation and examination of the images by the PI or designee. While there are no direct benefits for subjects in this study, the study hopes to improve the implementation of ultrasound into the clinical setting into the future. This Phase I study aims to examine the feasibility of implementation and the impact on the clinical setting. Additionally, this study hopes to examine the utility and usefulness of ultrasound in medical education and thereby hopes to improve the physical exam skills of clinicians for the future.
Read the detailed description
Ultrasound is a non-invasive, effective imaging methodology that is being used for many applications. The clinical availability of an ultra-portable app-based ultrasound system is a technology leap that has the potential to completely change the way ultrasound is used.
The objectives of this study are:
- Evaluate feasibility of use of a new app-based ultra-portable, ultrasound system in the clinical setting
- Review image quality and consistency of quality
- Examine the use of new app-based ultra-portable ultrasound as an extension of the physical exam and implementation into medical education
- Determine potential clinical applications, opportunities, and limits
- Perform intra-individual comparison to current clinical use ultrasound device
- Exam the perception and integration of new, ultra-portable ultrasound systems
- Determine the potential educational value to medical student experience
Experimental activities performed as a part of this research study are divided into three different categories based on participant population: Patient population: For these patients, the non-research activities will be their standard of care ultrasound examination or their ultrasound examination within another clinical research trial. For these participants, the experimental activities could involve four different scenarios: 1) Patient having a standard of care US and participates in the comparator assessment using the new or ultra-portable US technology, 2) Patient having a physical examination by a medical student, resident or physician, 3) Patient requiring vascular access, 4) Patient has a medical diagnosis and within this clinical trial the investigators will use and evaluate the new ultrasound technology regarding its potential of enabling novel application. For each of these scenarios, in addition to the investigational ultrasound examination, the patient will be given a questionnaire to give feedback from his or her perspective. Staff population: For the staff population, research activities will involve a questionnaire to provide feedback regarding the experience and perception of the ultraportable ultrasound technology at the completion of each ultrasound imaging session. Volunteer population: For these participants, all activities will be performed solely for the research study (i.e. there is no standard of care ultrasound examination). The investigators plan to have the volunteers involved in two different scenarios, which would all take place after informed consent has been given and documented: 1) Participation in a single ultrasound exam session, 2) Participation in multiple ultrasound exams and multiple operator sessions. In addition to receiving one or more ultrasound examinations, the volunteers will be asked to complete a questionnaire to provide feedback from his or her perspective regarding the ultraportable ultrasound technology.
- Conditions
- Portable Ultrasound
- Being tested
- Phillips Lumify Diagnostic Ultrasound System, Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phillips Lumify Diagnostic Ultrasound SystemDiagnostic test
portable ultrasound device
SurveysOther
surveys assessing perception of ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Patient population | Experimental | When a patient receives an ultrasound examination as part of standard of care or within another clinical research trial, such an examination may serve for an intra-individual comparator examination between conventional and new, ultra-portable ultrasound imaging. Patients will be identified in the clinical setting when appropriate and will be appropriately approached for consent for a combination of ultrasound with the physical exam, for medical student education, IV access, and novel application. Patients will be enrolled and accounted for in the appropriate sub-population. Receives: Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System; Other: Surveys |
| Healthy volunteer population | Experimental | The volunteer population will allow us to practice the use of this equipment and understand the limitations and applicability. The results will be the images acquired as well as surveys from the volunteers and those performing the scans, who will be enrolled in the staff population of this study. Receives: Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System; Other: Surveys |
| Student and staff population | Experimental | To understand the impact of ultraportable ultrasound, survey tools will be used to understand the workflow and clinical care applications and integration of these devices. All staff and student members will be appropriately consented; however, we anticipate that this portion of the study will be minimal risk. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Image Quality
Assessing the benefit of portable ultrasound to improve the capabilities of ultrasound imaging
Measured: through study completion, an average of 1-3 years
Perception of portable ultrasound
Measured: through study completion, an average of 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portable UltrasoundStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Third Frontier
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael V Knopp, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486444
- Sponsor's protocol ID
- RP0509/2017H0356
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2018
- Last updated
- 18 Jan 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications
- ClinicalTrials.gov ID
- NCT03486444
- Acronym / sponsor ID
- RP0509/2017H0356
- Conditions
- Portable Ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Ohio Third Frontier
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Apr 2018 (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.
This is a Phase I study to assess feasibility. There will be no impact on clinical care based on this study. The ultrasound system is FDA approved and could be used for clinical care independent of this research study. When a subject receives an ultrasound examination as part of standard of care or within another clinical research trial, such an examination may serve for an intra-individual comparator examination between conventional and new, ultra-portable ultrasound imaging. Patients will be identified in the clinical setting when appropriate and will be appropriately approached for consent for a combination of ultrasound with the physical exam, for medical student education, IV access, and novel application. Patients will be enrolled and accounted for in the appropriate sub-population. Additionally, to understand the impact of ultraportable ultrasound, survey tools will be used to understand the workflow and clinical care applications and integration of these devices. All staff and student members will be appropriately consented; however, the investigators anticipate that this portion of the study will be minimal risk with online consent waivers. Finally, the volunteer population will allow us to practice the use of this equipment and understand the limitations and applicability. The results will be the images acquired as well as surveys from the volunteers and those performing the scans, who will be enrolled in the staff population of this study. No significant risk is identified for subjects in this study. The largest risk, although still minimal, is an incidental finding. For this study, subjects will have the choice if they would like to be informed of an incidental finding. Reporting of incidental findings will be conducted by designated study staff after appropriate consultation and examination of the images by the PI or designee. While there are no direct benefits for subjects in this study, the study hopes to improve the implementation of ultrasound into the clinical setting into the future. This Phase I study aims to examine the feasibility of implementation and the impact on the clinical setting. Additionally, this study hopes to examine the utility and usefulness of ultrasound in medical education and thereby hopes to improve the physical exam skills of clinicians for the future.
Detailed description
Ultrasound is a non-invasive, effective imaging methodology that is being used for many applications. The clinical availability of an ultra-portable app-based ultrasound system is a technology leap that has the potential to completely change the way ultrasound is used.
The objectives of this study are:
- Evaluate feasibility of use of a new app-based ultra-portable, ultrasound system in the clinical setting
- Review image quality and consistency of quality
- Examine the use of new app-based ultra-portable ultrasound as an extension of the physical exam and implementation into medical education
- Determine potential clinical applications, opportunities, and limits
- Perform intra-individual comparison to current clinical use ultrasound device
- Exam the perception and integration of new, ultra-portable ultrasound systems
- Determine the potential educational value to medical student experience
Experimental activities performed as a part of this research study are divided into three different categories based on participant population: Patient population: For these patients, the non-research activities will be their standard of care ultrasound examination or their ultrasound examination within another clinical research trial. For these participants, the experimental activities could involve four different scenarios: 1) Patient having a standard of care US and participates in the comparator assessment using the new or ultra-portable US technology, 2) Patient having a physical examination by a medical student, resident or physician, 3) Patient requiring vascular access, 4) Patient has a medical diagnosis and within this clinical trial the investigators will use and evaluate the new ultrasound technology regarding its potential of enabling novel application. For each of these scenarios, in addition to the investigational ultrasound examination, the patient will be given a questionnaire to give feedback from his or her perspective. Staff population: For the staff population, research activities will involve a questionnaire to provide feedback regarding the experience and perception of the ultraportable ultrasound technology at the completion of each ultrasound imaging session. Volunteer population: For these participants, all activities will be performed solely for the research study (i.e. there is no standard of care ultrasound examination). The investigators plan to have the volunteers involved in two different scenarios, which would all take place after informed consent has been given and documented: 1) Participation in a single ultrasound exam session, 2) Participation in multiple ultrasound exams and multiple operator sessions. In addition to receiving one or more ultrasound examinations, the volunteers will be asked to complete a questionnaire to provide feedback from his or her perspective regarding the ultraportable ultrasound technology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient population | Experimental | Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System, Other: SurveysWhen a patient receives an ultrasound examination as part of standard of care or within another clinical research trial, such an examination may serve for an intra-individual comparator examination between conventional and new, ultra-portable ultrasound imaging. Patients will be identified in the clinical setting when appropriate and will be appropriately approached for consent for a combination of ultrasound with the physical exam, for medical student education, IV access, and novel application. Patients will be enrolled and accounted for in the appropriate sub-population. |
| Healthy volunteer population | Experimental | Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System, Other: SurveysThe volunteer population will allow us to practice the use of this equipment and understand the limitations and applicability. The results will be the images acquired as well as surveys from the volunteers and those performing the scans, who will be enrolled in the staff population of this study. |
| Student and staff population | Experimental | Other: SurveysTo understand the impact of ultraportable ultrasound, survey tools will be used to understand the workflow and clinical care applications and integration of these devices. All staff and student members will be appropriately consented; however, we anticipate that this portion of the study will be minimal risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects or patients greater than or equal to 18 years of age
- Patients who are capable of giving informed consent
Key exclusion criteria (2 listed)
- Prisoners
- Participants incapable of giving informed consent, even if they have a power of healthcare attorney who is clearly identifiable and available for the consenting process.
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 |
|---|---|---|
| Phillips Lumify Diagnostic Ultrasound Systemportable ultrasound device | Diagnostic test | Healthy volunteer population, Patient population |
| Surveyssurveys assessing perception of ultrasound | Other | Healthy volunteer population, Patient population, Student and staff population |
Primary outcome
Ultrasound Image Quality
Time frame: through study completion, an average of 1-3 years
Assessing the benefit of portable ultrasound to improve the capabilities of ultrasound imaging
Perception of portable ultrasound
Time frame: through study completion, an average of 1-3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
Michael V Knopp, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phillips Lumify Diagnostic Ultrasound System and Surveys in people with Portable Ultrasound, run by University of Cincinnati at 1 site 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Ultrasound Image Quality (time frame: through study completion, an average of 1-3 years). 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 18 Jan 2024.