Status:
COMPLETED
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Lead Sponsor:
Abionic SA
Collaborating Sponsors:
Boston Biomedical Associates
Ocean State Clinical Coordinating Center
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- Male or female, aged ≥ 18 years.
- Apparently healthy as determined by a subject questionnaire.
Exclusion
- 1\) 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
- 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.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04409561
Start Date
November 15 2021
End Date
January 15 2022
Last Update
March 2 2022
Active Locations (1)
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1
Mercy Health St. Vincent
Toledo, Ohio, United States, 43608