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

Completed

Conditions studied: Sepsis, Septic Shock, Healthy

In brief

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.

Key facts

Study ID

NCT04409561

Run by

Abionic SA

People needed

150

Starts

2021-11-15

Expected to finish

2022-01-15

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:
• Heart disease
• Stroke
• Renal disease
• Liver disease
• Pancreatic disease
• Chronic obstructive pulmonary disorder
• Bleeding disorders
• Hypercalcitoninemia
• HIV AIDS
• Receiving antibiotic therapy
• Suspected infection
• Immunosuppression
• Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
• Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.
• 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.
• Current diagnosis of cancer within the last 12 months.
• Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.
• Hospitalization for more than 24 hours within the last 3 months.
• Reported as currently pregnant or nursing a child
• Unable or unwilling to provide the required blood sample for testing.
• Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.

Where it is running

• Mercy Health St. Vincent — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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