Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications

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ClinicalTrials.gov Identifier: NCT03486444

Recruitment Status : Not yet recruiting

First Posted : April 3, 2018

Last Update Posted : October 8, 2021

See Contacts and Locations

Sponsor:

Collaborator:

Ohio Third Frontier

Information provided by (Responsible Party):

Michael V. Knopp MD, PhD, Ohio State University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Portable Ultrasound	Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System Other: Surveys	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	750 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications
Estimated Study Start Date :	March 1, 2022
Estimated Primary Completion Date :	December 31, 2024
Estimated Study Completion Date :	December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patient population 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.	Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System portable ultrasound device Other: Surveys surveys assessing perception of ultrasound
Experimental: Healthy volunteer population 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.	Diagnostic Test: Phillips Lumify Diagnostic Ultrasound System portable ultrasound device Other: Surveys surveys assessing perception of ultrasound
Experimental: Student and staff population 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.	Other: Surveys surveys assessing perception of ultrasound

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486444

Contacts

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Contact: Melanie Hughes	614-293-9998	office@wcibmi.org
Contact: Michael V Knopp, MD, PhD	614-293-9998	knopp.16@osu.edu

Locations

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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD
Sub-Investigator: Chadwick L Wright, MD, PhD
Sub-Investigator: David P Bahner, MD
Sub-Investigator: Gayle M Gordillo, MD

Sponsors and Collaborators

Ohio State University

Ohio Third Frontier

Investigators

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Principal Investigator:	Michael V Knopp, MD, PhD	Ohio State University

Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:

Study Protocol [PDF] October 12, 2017

More Information

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Responsible Party:	Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier:	NCT03486444
Other Study ID Numbers:	RP0509/2017H0356
First Posted:	April 3, 2018 Key Record Dates
Last Update Posted:	October 8, 2021
Last Verified:	October 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Product Manufactured in and Exported from the U.S.:	Yes

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