Trials / Completed
CompletedNCT05849935
abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003
A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 61 (actual)
- Sponsor
- Abionic SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-07-17
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2023-05-09
- Last updated
- 2023-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05849935. Inclusion in this directory is not an endorsement.