Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 3:34 AM
Study NCT ID:
NCT04780334
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2021-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Status:
COMPLETED
Status Verified Date:
2023-05
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:
COR-DIAL-S
Brief Summary:
The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.
The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.
The benefits would be
1. greater sensitivity
2. a great speed because 8tests could be performed at the same time with a result in a few minutes
3. a very high specificity at least equivalent to PCR.
This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.
The CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.
The benefits would be
1. greater sensitivity
2. a great speed because 8tests could be performed at the same time with a result in a few minutes
3. a very high specificity at least equivalent to PCR.
This new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A00387-34 | OTHER | ID-RCB number, ANSM | View |