Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-11 @ 2:39 PM
Study NCT ID:
NCT04409561
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Sponsor:
Abionic SA
Organization:
Study Overview
Official Title:
A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Status:
COMPLETED
Status Verified Date:
2022-02
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 is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.
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?:
None
Is an FDA AA801 Violation?: