Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-04 @ 1:59 PM
Study NCT ID:
NCT01914302
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Characterization of Blood Volumes of Commercially Available Lancing Devices
Sponsor:
Facet Technologies
Organization:
Study Overview
Official Title:
Lancing Device Blood Volume Study
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Detailed Description:
Primary Objective:
• Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:
* Correlation of Subject pain response to blood volume collected;
* Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
* Proportion of Subjects that generate ≥1µl blood volume;
* Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
* Proportion of Subjects who generate multiple- times ≥1µl of blood volume
* Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
* Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt
• Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:
* Correlation of Subject pain response to blood volume collected;
* Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
* Proportion of Subjects that generate ≥1µl blood volume;
* Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
* Proportion of Subjects who generate multiple- times ≥1µl of blood volume
* Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
* Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: