Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications
Phase: NA
Conditions: Portable Ultrasound
Sponsor: University of Cincinnati

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 1 of 15  
 09/13/2017 
 
Protocol Title: 
Exploring new and next generation ultrasound technologies 
for medical education, patient care, and new indications 
 
 
Protocol Project Number: 
 
RP0509 
 
Protocol Date: 
October 12, 2017 
 
Principal Investigators: 
 
Michael V. Knopp, MD, PhD 
Professor, Department of Radiology 
Novartis Chair of Imaging Research 
Distinguished University Scholar  
Vice-Chairman of Research 
The Ohio State University Wexner Medical Center 
395 West 12th Avenue, Room 430 
Columbus, Ohio 43210 
Phone: (614) 293-9998 
Fax: 
(614) 293-9275 
E-Mail: knopp.16@osu.edu 
 
 
 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 2 of 15  
 09/13/2017 
Study Team: 
Michael V Knopp, MD, PhD 
principal investigator 
Melanie Hughes 
informed consent, scheduling, administration 
Michelle I. Knopp, (MED 4) 
informed consent, data acquisition, data processing 
Sarah Spaulding 
informed consent, scheduling, data management 
Katherine Binzel, PhD 
informed consent, data acquisition, data processing 
Chadwick L. Wright, MD, PhD  
informed consent, data acquisition, data processing 
Melanie U. Knopp 
informed consent, data acquisition, data processing 
David Bahner, MD 
informed consent, data acquisition, data processing 
Gayle Gordillo, MD 
informed consent, data acquisition, data processing 
Samantha Kisare 
informed consent, data acquisition, regulatory  
Sarah Herald 
regulatory management 
 
 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 3 of 15  
 09/13/2017 
I. 
Overview  
Ultrasound (US) is an enabling, non-invasive, widely used clinical imaging technology that has 
evolved from very bulky equipment towards smaller and more portable systems in the last three 
decades. In 2015, a new technology milestone was achieved with the first commercial introduction 
of a smart app based device (Android based smart phone or tablet) utilizing a mirco-usb connected 
ultrasound probe that received 510K FDA approval. This extreme miniaturization has the potential 
to be disruptive and should enable new, refined, or modified approaches to use such an ultrasound 
system in healthcare.  
Ultrasound imaging requires three essential components:  
1. An ultrasound transducer that emits and receives the ultrasound waves - the app based 
system currently has two different transducers available, a linear array (straight contact 
area) for near field imaging such as vessels or subcutaneous structures and a curved array, 
for deeper tissue ultrasound wave penetration such as abdominal imaging 
2. The need for a contact medium such as ultrasound gel to create a continuous sound 
medium that is applied on the subject skin at the location of the desired anatomy. The gel 
is non allergic, non-toxic, water soluble, and readily wipes off 
3. A display and recording device to visualize the ultrasound reflections and save the 
reconstructed images as either DICOM or movie files 
Surprisingly, no clinical evaluation studies exploring new, refined, or modified approaches have 
yet been published using this ultra-portable technology, so that we decided to initiate this Phase I 
feasibility assessment study.  
Within this study we want to explore ultrasound in the following populations: 
A) Use of new ultra-portal ultrasound systems with patients in the clinical setting 
1. To compare to standard of care ultrasound studies to allow for intra-individual 
comparison 
2. As an extension of the physical exam for functions such as a virtual stethoscope by 
practitioners and trainees including medical students (not intended to replace clinical 
ultrasound) 
3. To investigate new applications of miniaturized ultrasound such as supporting the 
placement of intravenous access for delivery (infection / infusion) of imaging 
pharmaceuticals and/or pharmaceuticals or in wound care as complementary to 
standard of care treatments 
B) Examine how new generations of US systems handle from the perspective of personnel 
that typically uses such equipment such as physicians, students, and ultrasound 
technologists in the form of questions, interviews, online surveys, and free hand on 
preferences and experience 
C) For practice and understanding application of new generation ultrasound systems in 
volunteer populations outside of patient care 
 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 4 of 15  
 09/13/2017 
II. 
Objectives  
Aim 1:  
Evaluate feasibility of use of a new app-based ultra-portable, ultrasound system in the 
clinical setting  
Aim 2:  
Review image quality and consistency of quality 
Aim 3:  
Examine the use of new app-based ultra-portable ultrasound as an extension of the 
physical exam and implementation into medical education 
Aim 4:  
Determine potential clinical applications, opportunities, and limits  
Aim 5:  
Perform intra-individual comparison to current clinical use ultrasound device 
Aim 6:  
Exam the perception and integration of new, ultra-portable ultrasound systems 
Aim 7: 
Determine the potential educational value to medical student experience 
 
III. 
Background and Rationale 
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.  
Integrating the technology into the clinical setting could make ultrasound as vital as palpation 
during a physical exam.  
Medical schools across the country have started including ultrasound in the first two years of 
medical school. In fact, Loma Linda University has demonstrated improved standardized patient 
interview exam scores with the integration of ultrasound into the curriculum suggesting medical 
educational value in expanding implementation of ultrasound in improving physical exam skills 
of practitioners.  
Our team has extensive experience in exploring, developing, assessing and validating new medical 
imaging technology. This effort is intended to investigate and explore different use cases and 
acquire preliminary data to design specific future clinical trials (Phase III and Phase IV). 
It also must be highlighted that such innovative uses when well designed and integrated into 
appropriate diagnostic and care concepts might also be highly cost effective and practical in 
clinical use and have the potential to improve medical education. 
Without a rigorous exploration and preliminary data, we cannot systematically develop and 
validate new disruptive concepts; this is the essential basis for this clinical trial. 
As ultrasound is minimal risk and non-invasive, the subjects participating will not experience any 
additional risks.  They will only be asked to donate time for the additional use of the ultra-portable 
ultrasound system and to potentially grant permission for us to review their health record to 
compare scans conducted with new, ultraportable technology to that of standards of clinical care. 

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THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 7 of 15  
 09/13/2017 
A. 
Sample  
Patient Population 
We plan to enroll up to 450 subjects in this clinical feasibility exploration. We do not expect to 
enroll more than 150 subjects for any specific question.  
Intra-individual comparison to conventional ultrasound imaging (150 subjects)  
Assessment of utility of new, ultraportable ultrasound technology for medical student education 
and/or in combination with a physical examination (150 subjects) 
Assessment of utility of new, ultraportable ultrasound for IV access (100 subjects) 
Assessment of utility of new, ultraportable ultrasound for novel applications (50 subject) 
Staff (Physicians, Ultrasound technologists) and Student Population 
Staff working in imaging related healthcare environment and medical students will be enrolled to 
study the perception, advantages and disadvantages, and possible applications in a variety of 
settings. We plan to enroll up to 150 subjects to study the impact of new, ultraportable ultrasound 
on workflow and clinical care. Medical students and practitioners conducting research ultrasound 
imaging in the patient or volunteer population described above will be enrolled in this portion. 
Volunteer Population 
We plan to enroll up to 150 subjects who will be scanned using the ultraportable ultrasound in the 
feasibility exploration to develop best practices for this equipment, exam the feasibility and 
potential indications, and examine implementation concerns of ultraportable ultrasound.  
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 
B. 
Measurement / Instrumentation 
All devices will be operated according to the manufacture instruction manual. All ultrasound 
devices are FDA approved and will be used within the manufacture device settings. 
Comparison of ultraportable ultrasound with standard of care will be qualitative as well as 
quantitate where appropriate. A review of the new, ultraportable ultrasound images will be 
conducted by a trained reader/viewer to compare quality of images, positioning of the patient, time 
required for the study, limitations, and ability of capture appropriate anatomy.  
All patients consented to this study independently of what arm, will be asked to fill out a survey 
about their experience to assess appropriate use of the technology as well as to understand patient 
perception of the increased integration of ultrasound into the clinical environment.  

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 8 of 15  
 09/13/2017 
All operators of the ultraportable ultrasound will be asked to fill out a survey for each scan they 
conduct to collect data about the operator experience, settings of use, and implementation into the 
clinical setting.  
All survey tools will be available in printed as well as online format through a secure exchange. 
Subjects will be identified only by their coded ID and not identifiable information.  
Measurements will include quantitative satisfaction scores, qualitative comments, time required 
for scans, experience, and location of scan to help guide further development and implementation.  
C. 
Detailed study procedures 
Administration of informed consent 
Informed consent may be given at any time after the subject has had appropriate time to read the 
informed consent form and ask and receive answers to any questions.  
We prepared a training video for the trial staff to see how we would like to have the informed 
consent administered to all aspects of GCP, and applicable further guidelines will be appropriately 
reflected. 
The informed consent form may be given ahead of time or at the time just prior to start of the 
participation. 
Withdrawal from the study 
The subject can withdraw at any time from the study. At the time of a withdrawal, the subject may 
be asked if he or she wants to do a complete withdrawal or just wants to stop further participation 
and allows use of the already gathered data. 
Compensation for participation in the research 
Subjects will not be compensated for their participation in this study; they will be donating their 
time. 
Location of performance of research 
While the patient related research efforts will be exclusively performed at The Ohio State 
University Wexner Medical Center or its affiliated facilities, staff and volunteers may complete 
survey tools at any location of their preference.  
Staff and volunteer testing may be performed at any appropriate location and/or environment that 
is conducive to the performing of such testing at The Ohio State University. 
Ultrasound scanning 
The effective ultrasound imaging approach will vary by the specific situation that is detailed 
below: 
Patient Population 
We plan to have patients involved four in different scenarios, all after informed consent has been 
given and documented. 
Patient having a standard of care US and participates in the comparator assessment using the new 
or ultra-portable ultrasound technology. 
 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 9 of 15  
 09/13/2017 
In this situation, the patient will have an investigational ultrasound with the new technology either 
before or after the performance of the standard of care ultrasound examination. The sequence is 
not important and therefore can be adapted to what is most convenient for the patient or to the time 
management of the patient’s schedule. The investigational ultrasound may include any anatomic 
area to which the patient has no objection to be scanned including but not limited to the same 
anatomic area scanned as part of the standard of care ultrasound examination.  
In addition to the investigational ultrasound examination, the patient will be given a questionnaire 
to provide feedback from his or her perspective. 
Patient having a physical examination by a medical student, resident or physician. 
In this situation, an investigational ultrasound with the new technology may be performed as an 
extension of the physical examination. This ultrasound will not be used for any medical care 
decisions and does not replace any medically indicated ultrasound examination. It is solely 
performed for investigational purposes to assess the feasibility and potential utility of an ultra 
compact ultrasound technology. 
In addition to the investigational ultrasound examination, the patient will be given a questionnaire 
to provide feedback from his or her perspective. 
Patient requiring vascular access  
In this situation, investigational ultrasound will be performed for the sole purpose of identifying 
vascular structures in the area of desired vascular access. The typical scenario will be a technologist 
or other healthcare provider performing the vascular access procedure who would use the new 
ultrasound technology to identify vessels as well as to visualize if flow can be detected. 
In addition to the investigational ultrasound examination, the patient will be given a questionnaire 
to provide feedback from his or her perspective. 
Patient has a medical diagnosis and within this clinical trial we will use and evaluate the new 
ultrasound technology regarding its potential of enabling novel application. This ultrasound will 
not be used for any medical care decisions and does not replace any medically indicated ultrasound 
examination. It is solely performed for investigational purposes to assess the feasibility and 
potential utility of an ultra compact ultrasound technology to help in management of the patient 
situation. 
In addition to the investigational ultrasound examination, the patient will be given a questionnaire 
to provide feedback from his or her perspective. 
Staff Population 
Any operator of the new, ultraportable ultrasound technology will have the option to enroll in this 
trial, as we want to also assess the experience and perception of the operator. The operator of the 
ultrasound device for the purpose of this investigational assessment may be technologists, 
physicians, fellows, residents, medical students, nurses, physician extenders, or other healthcare 
or health technology professionals or students in training of those professions. 
Before any operator will be allowed to use the investigational ultrasound system, they will need to 
go through a training session in which they demonstrate that they have familiarized themselves 
with the technology and are able to appropriately operate the device. The current user manual of 
the Lumify ultrasound or other applicable devices will be provided prior to the training session. 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 10 of 15  
 09/13/2017 
The staff operator will have to demonstrate his or her ability to operate the system as well as to 
document their understanding of this protocol. The completion of this training/review session for 
the purpose of this clinical trial will be documented in the training log. The training will be 
performed by the PI or after completion of prior training by a designee. 
The Staff will be given a questionnaire to provide feedback from his or her perspective after 
completion of every ultrasound imaging session. 
Other appropriately training staff / physicians will assist the PI in the image review of the recorded 
images, and the findings will be documented using a survey tool.  
Staff has also the option to withdraw from participation of this trial at any time. 
Volunteer Population 
We plan to have volunteers involved in two different scenarios, all after informed consent has been 
given and documented. 
Participation in a single ultrasound exam session 
In this situation, the healthy volunteer will allow the performance of an investigational ultrasound 
session with the new technology. The investigational ultrasound may include any anatomic area 
to which the patient has no objection to being scanned. The typically single scan session will take 
20 – 30 minutes. 
Ultrasound images will be captured that will be reviewed by the PI or experience designee 
regarding the quality, potential diagnostic use, extent of artifacts or any other observation. 
In addition to the ultrasound examination, the participant will be given a questionnaire to give 
feedback from his or her perspective. 
Participation in a multiple ultrasound exams and multiple operator sessions 
In this situation, the healthy volunteer will allow the performance of an investigational ultrasound 
including multiple ultrasound exams and multiple operator sessions with the new technology. The 
investigational ultrasound may include any anatomic area to which the patient has no objection to 
being scanned. The typically multiple scan / multiple operator session will take 90 – 120 minutes. 
Ultrasound images will be captured that will be reviewed by the PI or experience designee 
regarding the quality, potential diagnostic use, extent of artifacts or any other observation. 
In addition to the ultrasound examinations, the participant will be given a questionnaire to give 
feedback from his or her perspective. 
Survey / Questionnaire tools 
The following survey / answer capture tools will be utilized that will be preferentially captured via 
a web tool on a smart / tablet device or alternatively in paper hard copy. If electronic data capture 
is used, the captured data will be archived to insure that they can serve as source documents. 
• Patient Survey  
• Volunteer Survey 
• Staff Registration Survey 
• Staff Operator Exam Feedback Survey 
• Staff Assessment of Imaging Exam Survey 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 11 of 15  
 09/13/2017 
Incidental findings 
Anytime an imaging study is preformed, there is some risk that an incidental finding in observed. 
There will be minimal risk or likelihood in the patient population, as they are already undergoing 
standard of care ultrasound or physical exams.  
The risk or likelihood will be slightly higher in the volunteer population as they will not be 
receiving standard of care studies. Informed consent form does ask subjects to identify if they 
would like to be directly informed of an incidental finding and if this finding should be 
communicated to the health care provider of their choice.  
Incidental findings are not intended to be released to patients or subjects at the time of the scan 
and are part of the reporting survey that will be filled out at the end of each study. These reports 
will be gathered and reviewed by the PI or appropriate delegates to determine the appropriate level 
of next steps. The communication will follow the choice indicated on the ICF form.  
Data analysis and analytics 
As this is an exploratory trial, we have no prior data available to develop a detailed analysis plan. 
We will perform descriptive statistics and assess relationships between the preferences and 
observed data gathered from the survey tools and/or noninvasive measurement. We will consult 
statistical expertise at different phases of data gathering to review data capture and tabulation 
procedures as well as explore data analysis strategies. 
Data sharing 
Coded or de-identified data may be shared with other research projects as additional information 
or for benchmarking observations. Data may be shared for further analysis with research teams at 
The Ohio State University or outside. The data sharing agreements would be documented and 
executed prior to sharing of data according to The Ohio State University policies. 
De-identified data may be placed in public databases, especially if it is required by funding 
agencies such as National Institutes of Health, National Science Foundation, and others. 
D. 
Risk, Benefits, Safety, and Confidentiality  
Risks 
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.  
Benefits 
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.  

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 12 of 15  
 09/13/2017 
Safety Monitoring 
No formal safety monitoring will be necessary; however, a regular review of data to identify any 
concerns from patients and staff will be performed. Any safety concerns or observations will be 
presented to the PI in a timely manner and addressed in a reasonable timeframe.  
Confidentiality of Records 
Patient Population 
Patient populations will be identified using coded IDs assigned at the time of the signing of the 
informed consent. From that point forward the patient will only be identified by the coded ID. 
When clinical data is accessed and retrieved to compare study images to standard of care 
ultrasound images and report, all data that will be managed and recorded will be coded. 
Staff Population 
Only for the purpose of identifying a subject regarding participation and potential regulatory 
follow-up, a single coding identification sheet will be kept. All other data points will be generated 
in coded data structures. 
There will be no linkage of any information regarding participation in this study or any HR 
documentation. Participation in this study will in no way affect any performance or educational 
assessment review. 
Volunteer Population 
Only for the purpose of identifying a subject regarding participation and potential regulatory 
follow-up, a single coding identification sheet will be kept. All other data points will be generated 
in coded data structures. 
E. 
Internal Validity 
Managing and verifying the internal validity is an important task in this exploratory research 
program in order to develop the appropriate methodology to be validated in prospective clinical 
trials.  
As there is an opportunity that the ultrasound operator can potentially bias the subject, we will 
perform training sessions prior to them participating. We will also perform from time to time an 
observational assessment by a study member participating in the project with the task to observe 
the ultrasound operator to ensure that no bias or systematic errors occur.  
In this exploratory study where we use image and observation-based assessments, we will have to 
constantly assess the potential sources of systematic errors or bias in order to ensure that we may 
derive conclusions that warrant generalization to other contexts. 
We will assess the different factors impacting internal validity of the data sets we generate. For 
the specific factors we will address the following considerations: 
The following text uses material presented at https://en.wikipedia.org/wiki/Internal_validity and 
is hereby specifically acknowledged. 
Temporal precedence 
Potential lack of clarity how one experience may influence a subsequent experience as that might 
be a cause and effect relationship. 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
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 09/13/2017 
Confounding 
A major threat to the validity of causal inferences is confounding. Observations in one variable 
may relate to another manipulated variable. Where spurious relationships cannot be ruled out, 
hypotheses would have to be appropriately developed. 
Selection bias 
Selection bias refers to the problem that, at pre-test, differences between groups exist that may 
interact with the independent variable and thus be 'responsible' for the observed outcome. 
Researchers and participants bring to the experiment a myriad of characteristics, some learned and 
others inherent. For example, sex, weight, hair, eye, and skin color, personality, mental 
capabilities, and physical abilities, but also attitudes like motivation or willingness to participate. 
During the selection step of the research study, if an unequal number of test subjects have similar 
subject-related variables there is a threat to the internal validity. If subjects in two groups to be 
compared are not alike with regard to the independent variable, but similar in one or more of the 
subject-related variables, it may jeopardize the internal validity. 
Self-selection to participate in this research can have a negative effect on the interpretive power of 
the dependent variable, this is especially known for online surveys where individuals of specific 
demographics opt into the test at higher rates than other demographics. 
History 
Events outside of the study/experiment or between repeated measures of the dependent variable 
may affect participants' responses to experimental experiences. Often, these are large scale events 
(natural disaster, political change, etc.) that affect participants' attitudes and behaviors such that it 
becomes impossible to determine whether any change on the dependent measures is due to the 
independent variable, or the historical event. 
Maturation 
Subjects may change during the course of the experiment or even between measurements. Both 
permanent changes, such as physical growth and temporary ones like fatigue, provide "natural" 
alternative explanations; thus, they may change the way a subject would react to the independent 
variable. So, upon completion of the study, the researcher may not be able to determine if the cause 
of the discrepancy is due to time or the independent variable. 
Repeated testing 
Repeatedly measuring the participants may lead to bias. Participants may remember the answers 
or may be conditioned to know that they are being tested. Repeatedly taking (the same or similar) 
tests usually leads to score gains. 
Instrument change 
The instrument used during the testing process can change the experiment, an aspect that we will 
managed via device quality control to the largest extent possible. This also refers to observers 
being more concentrated or primed, or having unconsciously changed the criteria they use to make 
judgments. This can also be an issue with self-report measures such as facility perceptions given 
at different times. In this case the impact may be mitigated through the use of retrospective 
pretesting. If any instrumentation changes occur, the internal validity of the main conclusion is 
affected. 

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 Page 14 of 15  
 09/13/2017 
Differential attrition 
This error occurs if inferences are made on the basis of only those participants that have 
participated from the start to the end. However, participants may have dropped out of the study 
before completion, and maybe even due to the study or experiment itself. If this attrition is 
systematically related to any feature of the study, the administration of the independent variable, 
the instrumentation, or if dropping out leads to relevant bias between groups, a whole class of 
alternative explanations may be possible that account for the observed differences. 
Selection-maturation interaction 
This occurs when the subject-related variables (color of hair, skin color, etc.) and the time-related 
variables (age, physical size, etc.), interact. If a discrepancy between the two groups occurs 
between the testing, the discrepancy may be due to the age differences in the age categories. 
Experimenter bias 
Experimenter bias occurs when the individuals who are conducting an experiment inadvertently 
affect the outcome by non-consciously behaving in different ways to members of control and 
experimental groups. It is possible to eliminate the possibility of experimenter bias through the use 
of double blind study designs, in which the experimenter is not aware of the condition to which a 
participant belongs. 
F. 
Data Analysis 
At this point we intend to only use descriptive statistics as all aspects of this research are 
exploratory. Upon further data analytics we will consult with the biostatistician when we explore 
more definitive statistical assessments. 
Funding support 
This project is supported by the Ohio Third Frontier Wright-Center for Innovation in Biomedical 
Imaging project TECH 09-028 and the Wright Center of Innovation development fund. 
 
V. 
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