Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889937
Status:
RECRUITING
Last Update Posted:
2023-03-20
First Post:
2021-05-11
Brief Title:
Usability Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Sponsor:
Leuko Labs Inc
Organization:
Leuko Labs Inc
Study Overview
Official Title:
A Study to Evaluate the Usability Adherence and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Status:
RECRUITING
Status Verified Date:
2023-03
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:
PC004
Brief Summary:
Single-site non-significant risk open-label clinical investigation designed to validate the usability adherence and preliminary diagnostic performance of a novel technology to detect neutropenia Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None