Status:
COMPLETED
UNITE Study (UMN-SW) for COVID-19
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
SecondWave Systems Inc.
DARPA (United States Department of Defense)
Conditions:
Covid19
Cytokine Storm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 2...
Detailed Description
Ultrasound is widely used in human medicine because it is safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able...
Eligibility Criteria
Inclusion
- Age 18 and above
- Positive for SARS-CoV-2 (via PCR)
- Decreased blood oxygen saturation: Room air SaO2 \< 94% and/or requiring supplemental oxygen at a flow rate of 2 L/min or greater
- Admission to the hospital
Exclusion
- Pregnant women
- Asplenia
- Ascites
- Open wound/sores near the stimulation site
- Recent abdominal surgery
- Splenomegaly
- Mechanically ventilated (if patient goes onto mechanical ventilation while participating in the study, they can continue ultrasound treatment if recommended by SOC clinician and investigators of this study)
- Comfort care status
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04854798
Start Date
April 29 2021
End Date
February 11 2022
Last Update
May 3 2024
Active Locations (2)
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1
M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
2
M Health Fairview St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102