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

Sepsis Clinical Trial

— AB-PSP-007  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849935
• Other study ID #: AB-PSP-007
• Status: Completed
• Start date: July 17, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2023
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

Diagnostic Test:
• abioSCOPE
The abioSCOPE device with the PSP assay is intended to be indicated for ICU admitted patients at risk of developing sepsis. Results of abioSCOPE PSP assay may aid to identify sepsis in critically ill patients, together with all other clinical assessment and laboratory findings.

Locations

Country	Name	City	State
United States	Sundance Clinical	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Abionic SA	Avania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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