Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT05041595
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lyme Disease Diagnostic Assay - Collection of Whole Blood
Sponsor:
DiaSorin Inc.
Organization:
Study Overview
Official Title:
Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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 primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease.
In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Detailed Description:
Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.
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?: