Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
ConditionRight-To-Left Shunt
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAgitated Solutions, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt
Patient must be at least 18 years of age inclusive, at the time of signing the informed consent
Able to communicate effectively with trial personnel
Disqualifiers
Female patients who are pregnant or lactating. All women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening regardless of contraceptive use history
WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to ASI-02 dose administration
Allergy to polysorbate 80 (PS-80)
American Society of Anesthesiologists (ASA) physical status classification IV, V, or VI, except that participants with ASA physical status IV due solely to recent suspected transient ischemic attack or cerebrovascular accident are eligible for inclusion
Trial design
Treatments tested in this trial
- Agitated Saline SoC
- ASI-02
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Agitated Solutions, Inc.
Lead sponsor
Bright Research Partners
Collaborator
Source ClinicalTrials.gov