abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003 (AB-PSP-007)

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

This is a monocentric, 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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: abioSCOPE

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult healthy population

Description

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. Renal disease
   2. Stoke
   3. Liver disease
   4. Pancreatic disease (including diabetes)
   5. HIV AIDS
   6. Receiving antibiotic therapy
   7. Suspected infection
   8. Immunosuppression
2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
3. Current diagnosis of uncontrolled diabetes.
4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
6. Diagnosis and/or treatment of cancer within the last 12 months.
7. Received immunosuppressive therapy.
8. Hospitalization for more than 24 hours within the last month.
9. Reported as currently pregnant or nursing a child
10. Unable or unwilling to provide the required blood sample for testing.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Abionic SA
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AB-PSP-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No