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Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Sponsor: Agitated Solutions, Inc.
Summary
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.
Official title: A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-11-05
Completion Date
2026-06
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Agitated Saline SoC
The recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline.
ASI-02
Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air.
Locations (5)
Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
NYU Langone Health
New York, New York, United States
Toronto General
Toronto, Canada