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NCT06938347 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Right-To-Left Shunt, sponsored by Agitated Solutions.

Recruiting
Registry status
Phase 3
Development phase
300
Enrollment target
5
Study locations

NCT06938347: Recruiting Phase 3 study of Right-To-Left Shunt, sponsored by Agitated Solutions.

NCT06938347 is a Phase 3 study of Right-To-Left Shunt that is actively recruiting participants, run by Agitated Solutions. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06938347, a Phase 3 study of Right-To-Left Shunt, is actively recruiting participants, sponsored by Agitated Solutions.

RECRUITING
Registry status
Phase 3
Development phase
300 participants
Enrollment target
5
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Agitated Saline SoC
  • DRUG ASI-02

Study Locations (5)

Illinois

  • Northwestern University - Chicago

Minnesota

  • Mayo Clinic - Rochester

Mississippi

  • Jackson Heart Clinic - Jackson

New York

  • NYU Langone Health - New York

Other

  • Toronto General - Toronto

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2025-11-05
Est. Completion 2026-06
Phase Phase 3
Agitated Solutions

1 total trials

What NCT06938347 shows while recruiting

NCT06938347 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).

The record links to 1 condition, with Right-To-Left Shunt appearing as the primary indexed condition, and to 2 interventions - of which Agitated Saline SoC is the first listed.

NCT06938347 lists 5 locations in 5 states (Illinois, Minnesota, Mississippi).

Frequently Asked Questions

What is clinical trial NCT06938347 about?

NCT06938347 is a clinical study titled "Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt". 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.

What is the current status of trial NCT06938347?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2025-11-05. Estimated completion is 2026-06.

What conditions does trial NCT06938347 study?

This clinical trial studies the following conditions: Right-To-Left Shunt.

What interventions are being tested in trial NCT06938347?

The interventions under investigation include: Agitated Saline SoC (DRUG), ASI-02 (DRUG).

Who is sponsoring clinical trial NCT06938347?

This trial is sponsored by Agitated Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06938347 being conducted?

This trial has 5 study locations across Illinois, Minnesota, Mississippi, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06938347's enrollment target sits among peer trials

300 1123rd of 2000 higher than 840 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06938347, the US trial registry maintained by the National Library of Medicine. NCT06938347 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.