Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT05981495
Status:
UNKNOWN
Last Update Posted:
2023-08-08
First Post:
2023-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Sponsor:
NanoPin Technologies, Inc.
Organization:
Study Overview
Official Title:
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
NOT_YET_RECRUITING
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 goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease.
The main question\[s\] it aims to answer are:
* How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?
* How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?
Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.
The main question\[s\] it aims to answer are:
* How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?
* How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?
Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.
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?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: