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

NCT03486444 | Withdrawn FDA Device

• 1 other identifier: RP0509/2017H0356
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Portable Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Patient population

EXPERIMENTAL

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; Other: Surveys

Healthy volunteer population

EXPERIMENTAL

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; Other: Surveys

Student and staff population

EXPERIMENTAL

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

Interventions

Phillips Lumify Diagnostic Ultrasound System DIAGNOSTIC_TEST

portable ultrasound device

Healthy volunteer population; Patient population

Surveys OTHER

surveys assessing perception of ultrasound

Healthy volunteer population; Patient population; Student and staff population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects or patients greater than or equal to 18 years of age
• Patients who are capable of giving informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Ohio Third Frontier: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael V Knopp, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: April 3, 2018
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)