Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 12:32 PM
Study NCT ID:
NCT05018234
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2021-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Status:
COMPLETED
Status Verified Date:
2022-05
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:
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.
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?: