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Completed

NCT Number: NCT05849935

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sundance Clinical

St Louis, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged ≥ 18 years.
  • Apparently healthy as determined by a subject questionnaire.

Exclusion criteria

  • Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to
  • Renal disease
  • Stoke
  • Liver disease
  • Pancreatic disease (including diabetes)
  • HIV AIDS
  • Receiving antibiotic therapy
  • Suspected infection
  • Immunosuppression
  • Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
  • Current diagnosis of uncontrolled diabetes.
  • Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
  • Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
  • Diagnosis and/or treatment of cancer within the last 12 months.
  • Received immunosuppressive therapy.
  • Hospitalization for more than 24 hours within the last month.
  • Reported as currently pregnant or nursing a child
  • Unable or unwilling to provide the required blood sample for testing.

Treatment and study plan

abioSCOPE

Diagnostic Test

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.

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 2 months

Sponsors and collaborators

Lead sponsor

Abionic SA

Industry

Collaborators

  • Avania

Registry information

Official study title

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

Acronym: AB-PSP-007

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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