abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003

Completed

• Conditions: Sepsis

• Registration Number: NCT05849935
• Lead Sponsor: Abionic SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Status Verified: 2023-07
• Study Start: 2023-07-17
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sundance Clinical; 🇺🇸 Saint Louis, Missouri, United States