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

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.

Conditions

• Portable Ultrasound

Interventions

DIAGNOSTIC_TEST

Phillips Lumify Diagnostic Ultrasound System

portable ultrasound device

OTHER

Surveys

surveys assessing perception of ultrasound

Sponsors & Collaborators

• Ohio Third Frontier

  collaborator OTHER

• University of Cincinnati

  lead OTHER

Principal Investigators

• Michael V Knopp, MD, PhD · Ohio State University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• United States

Study Locations