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UNITE Study (UMN-SW) for COVID-19

NCT04854798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-03

No results posted yet for this study

Summary

The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen using a small wearable ultrasound system to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study using an early stage prototype device.

Specific Aims:

1. Determine the feasibility of splenic ultrasound with a prototype wearable device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and
2. Evaluate the potential capabilities of splenic ultrasound with this prototype wearable device in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group.

Conditions

Interventions

DEVICE

Splenic Ultrasound

Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care

Sponsors & Collaborators

  • SecondWave Systems Inc.

    collaborator INDUSTRY

  • DARPA (United States Department of Defense)

    collaborator UNKNOWN

  • MCDC (United States Department of Defense)

    collaborator UNKNOWN

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Erik Peterson, M.D. · University of Minnesota

  • Andrew Olson, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2022-02-01
Completion
2022-02-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854798 on ClinicalTrials.gov