Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-29 @ 6:34 PM
Study NCT ID:
NCT02742259
Status:
WITHDRAWN
Last Update Posted:
2019-03-26
First Post:
2016-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Prostate Cancer Assay - Beta+Pivotal
Sponsor:
Celsee Diagnostics
Organization:
Study Overview
Official Title:
Prospective, Multi-Center Validation of the Prostate Cancer Assay
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrolled participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VPCA-B+PIV
Brief Summary:
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.
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?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: