Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

Completed

• Conditions: Healthy; Sepsis; Septic Shock
• Interventions: Device: Blood collection

• Registration Number: NCT04409561
• Lead Sponsor: Abionic SA

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

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-01
• Study Start: 2021-11-15
• Primary Completion: 2021-11-15
• Study Completion: 2022-01-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or female, aged ≥ 18 years.
2. Apparently healthy as determined by a subject questionnaire.

Exclusion Criteria

1. Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:

1. Heart disease

2. Stroke

3. Renal disease

4. Liver disease

5. Pancreatic disease

6. Chronic obstructive pulmonary disorder

7. Bleeding disorders

8. Hypercalcitoninemia

9. HIV AIDS

10. Receiving antibiotic therapy

11. Suspected infection

12. Immunosuppression

    2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.

    3. Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.

    4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.

    5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care.

    6. Current diagnosis of cancer within the last 12 months.

    7. Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.

    8. Hospitalization for more than 24 hours within the last 3 months.

    9. Reported as currently pregnant or nursing a child

    10. Unable or unwilling to provide the required blood sample for testing.

    11. Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventions	Blood collection	This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.

Primary Outcome Measures

Name	Time	Method
Determination of reference range interval of PSP	Day 1	To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.

Secondary Outcome Measures

Name	Time	Method
Obtain well characterised samples library to be used for future tests development	Day 1	Whole blood collection from 150 healthy subject to be used for future tests development.
Collect medical data of healthy volunteer	Day 1	To collect medical data from the 150 study participants using a volunteer questionnaire

Trial Locations

Locations (1)

Mercy Health St. Vincent; 🇺🇸 Toledo, Ohio, United States