Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570044
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Evaluation of PerioMonitor for Detection of Oral Inflammatory OI in Human Subjects in Medical Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of PerioMonitor for Detection of Oral Inflammatory OI in Human Subjects in Medical Practice
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the usability of PerioMonitor in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation
PerioMonitor is an In Vitro Diagnostic IVD device intended as an aid in the detection of oral inflammation in individuals of 18 years and older This test is intended for use at point-of-care POC sites by health care professionals eg physicians nurses medical assistants dentists dental hygienists and dental assistants
PerioMonitor is an In Vitro Diagnostic IVD device intended as an aid in the detection of oral inflammation in individuals of 18 years and older This test is intended for use at point-of-care POC sites by health care professionals eg physicians nurses medical assistants dentists dental hygienists and dental assistants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None