Trial NCT03054870

View at ClinicalTrials.gov 
Org. Study IDs: CYC-009

Last trial update was posted on 2021-09-24

MeSH Interventions

Xenon

MeSH Conditions


Other Conditions

Lung Structure Determination

Stopping Reasons

Trial met primary efficacy endpoint target. No additional subjects necessary.

Limitations And Caveats

Unblinded analysis of imaging efficacy data was to be done at completion of study and all blinded readings. Due to the COVID-19 pandemic impact on enrollment, FDA recommended an unplanned interim analysis be performed using blind read data from 200 subjects. Interim analysis was done by independent 3rd party statistician and reviewed by a Data Efficacy Monitoring Committee (DEMC), which recommended termination of the study based on positive results. Sponsor agreed.

Result Publications

N/A

Annotations

Category Annotations
No annotators decided on categories yet

Intervention Annotations
# Outdated Intervention Condition
Name Route DrugBank ID