Diagnostic Accuracy of Handheld vs Traditional Ultrasound

NCT05196776 | Completed Results FDA Device

• 1 other identifier: 28766
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.

Conditions

Image, Body

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).

  1 day

Secondary Outcomes (1)

• Image Quality by Expert Review

  1 day

Study Arms (2)

Portable, Handheld Device

EXPERIMENTAL

Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device.

Device: Portable, handheld point-of-care ultrasound device

Traditional, Cart-based Ultrasound

ACTIVE COMPARATOR

Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine.

Device: Cart-based point-of-care ultrasound device

Interventions

Portable, handheld point-of-care ultrasound device DEVICE

The patient will have an ultrasound performed using a handheld, portable device.

Portable, Handheld Device

Cart-based point-of-care ultrasound device DEVICE

The patient will have an ultrasound performed using a traditional cart-based model.

Traditional, Cart-based Ultrasound

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.

You may not qualify if:

• All other non-English and non-Spanish speaking patients
• Vulnerable groups
• Patients unable to consent

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Results Point of Contact

• Title: Ryan Gibbons
• Organization: Temple University Hospital

ryan.gibbons@tuhs.temple.edu

2157075522

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 19, 2022
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)