Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT02224612
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2014-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Sponsor:
Medline Industries
Organization:
Study Overview
Official Title:
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compare the fit of two pediatric face masks in children.
Detailed Description:
This is a prospective, randomized, open-label comparative observational study to be conducted in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age). The usage of face masks is common practice within hospitals, and masks may be evaluated outside of clinical facilities as well.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: