Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Sponsor
Abionic SA (Industry)
Overall Status
Completed
CT.gov ID
NCT05627076
Collaborator
(none)
46
1
2.1
22.2

Study Details

Study Description

Brief Summary

Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood Sampling

Study Design

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Actual Study Start Date :
Aug 29, 2022
Actual Primary Completion Date :
Oct 11, 2022
Actual Study Completion Date :
Oct 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Primary assessment [through study completion, an average of 1.5 months]

    Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;

  2. Male or female, 18 years of age or older;

  3. Patient admitted to hospital

  4. Need for venous and arterial blood samples as part of standard of care

  5. Covered by a social security scheme.

Exclusion Criteria:
  1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;

  2. Subject under juridical protection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Limoges, RĂ©animation Polyvalente Limoges France 87042

Sponsors and Collaborators

  • Abionic SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abionic SA
ClinicalTrials.gov Identifier:
NCT05627076
Other Study ID Numbers:
  • AB-PSP-006
First Posted:
Nov 25, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abionic SA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2022