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

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.

Study Overview

• Status: Withdrawn
• Conditions: Portable Ultrasound
• Intervention / Treatment: Diagnostic test: Phillips Lumify Diagnostic Ultrasound System; Other: Surveys

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:

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Image Quality	Assessing the benefit of portable ultrasound to improve the capabilities of ultrasound imaging	through study completion, an average of 1-3 years
Perception of portable ultrasound		through study completion, an average of 1-3 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Ohio Third Frontier
• Investigators: Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RP0509/2017H0356

Drug and device information, study documents

• 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