Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06112301
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-10-20
Brief Title:
Pivotal Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Sponsor:
Invivoscribe Inc
Organization:
Invivoscribe Inc
Study Overview
Official Title:
Pivotal Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Status:
RECRUITING
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:
This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH IC IGH Dx Assay The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood PB samples from individuals with suspected B-Cell Lymphoproliferations The predicate device will be the LymphoTrack Dx IGH FR1FR2FR3 Assays - MiSeq LT Dx IGH-CE-IVD which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None