Clinical Trial

Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

Study acronym: ENHANCE
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06 -> 2026-09 2026-07-07
minor Completion pushed: 2026-06 -> 2026-09 2026-07-07
Trial Details
NCT Number NCT06938347
Lead Sponsor Agitated Solutions, Inc.
Collaborators: Bright Research Partners
Conditions Right-To-Left Shunt
Enrollment 300 participants
Start Date 2025-11-05
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-06