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
1 other identifier
observational
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedAugust 14, 2023
July 1, 2023
14 days
April 28, 2023
August 10, 2023
Conditions
Outcome Measures
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.
through study completion, an average of 2 months
Interventions
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.
Eligibility Criteria
Adult healthy population
You may qualify if:
- Male or female, aged ≥ 18 years.
- Apparently healthy as determined by a subject questionnaire.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abionic SAlead
- Avaniacollaborator
Study Sites (1)
Sundance Clinical
St Louis, Missouri, 63141, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 9, 2023
Study Start
July 17, 2023
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
August 14, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share