Clinical trial NCT04409561: Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Official title: A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Healthy
Keywords: Sepsis
Pancreatic Stone Protein
Immunoassay
Abionic
Healthy population
Point-of-care device
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
Collaborators: name: Boston Biomedical Associates
name: Ocean State Clinical Coordinating Center
First posted: 2020-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 generally healthy adults. 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of reference range interval of PSP
timeFrame: Day 1
Secondary outcomes:
measure: Collect medical data of healthy volunteer
timeFrame: Day 1
measure: Obtain well characterised samples library to be used for future tests development
timeFrame: Day 1
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Mercy Health St. Vincent
state: Ohio
Study officials:
References: