Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/23/2018 |
| Start Date: | July 1, 2018 |
| End Date: | February 19, 2021 |
| Contact: | Melanie Hughes |
| Email: | office@wcibmi.org |
| Phone: | 614-293-9998 |
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.
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.
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:
1. Evaluate feasibility of use of a new app-based ultra-portable, ultrasound system in the
clinical setting
2. Review image quality and consistency of quality
3. Examine the use of new app-based ultra-portable ultrasound as an extension of the
physical exam and implementation into medical education
4. Determine potential clinical applications, opportunities, and limits
5. Perform intra-individual comparison to current clinical use ultrasound device
6. Exam the perception and integration of new, ultra-portable ultrasound systems
7. 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.
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:
1. Evaluate feasibility of use of a new app-based ultra-portable, ultrasound system in the
clinical setting
2. Review image quality and consistency of quality
3. Examine the use of new app-based ultra-portable ultrasound as an extension of the
physical exam and implementation into medical education
4. Determine potential clinical applications, opportunities, and limits
5. Perform intra-individual comparison to current clinical use ultrasound device
6. Exam the perception and integration of new, ultra-portable ultrasound systems
7. 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.
Inclusion Criteria:
- Male and female subjects or patients greater than or equal to 18 years of age
- Patients who are capable of giving informed consent
Exclusion Criteria:
- 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.
We found this trial at
1
site
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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