Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-27 @ 2:24 PM
Study NCT ID:
NCT05022368
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2021-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Device Clinical Trial
Sponsor:
Nationwide Children's Hospital
Organization:
Study Overview
Official Title:
Surgical Safety Device Use During Transoral Surgery
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ENROLLING_BY_INVITATION
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:
The investigators are studying the use of a new medical device developed at Nationwide Children's. This technology has been licensed and produced by Zotarix LLC, a medical device company. It is designed to aid in retraction and provide protection of the lips during surgery. The investigators are not recording any of your identifiable personal health information except for the surgery date. This device, called the LabraGuard is a sterile, soft medical grade silicone, and no alternative device with these exact protective properties exists, and the investigators are trying to learn more about how it performs in different age children.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: