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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409561
• Other study ID #: AB-PSP-003
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2022
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 15, 2022
• Est. primary completion date: November 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Device:
• Blood collection
9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

Locations

Country	Name	City	State
United States	Mercy Health St. Vincent	Toledo	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Abionic SA	Boston Biomedical Associates, Ocean State Clinical Coordinating Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of reference range interval of PSP	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.	Day 1
Secondary	Collect medical data of healthy volunteer	To collect medical data from the 150 study participants using a volunteer questionnaire	Day 1
Secondary	Obtain well characterised samples library to be used for future tests development	Whole blood collection from 150 healthy subject to be used for future tests development.	Day 1