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NCT04409561
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
trial testing Blood collection in Sepsis in 150 participants. Completed in 15 January 2022.
15 November 2021
Quick facts
| Lead sponsor | Abionic SA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 15 November 2021 |
| Primary completion | 15 November 2021 |
| Estimated completion | 15 January 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood collection — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
- Septic Shock — all drugs for Septic Shock →
- Healthy — all drugs for Healthy →
Sponsor
Abionic SA
Who can join
18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single center, 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Examining pancreatic stone protein response in ICU-acquired bloodstream infections: a matched event analysis.
Verlaan D, Derde LPG, van der Poll T, Bonten MJM, et al · · 2024 · cited 2× · PMID 38805144 · DOI 10.1186/s40635-024-00634-7
Verify or expand the search:
- PubMed search for NCT04409561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07075107 — Transcriptomic Analysis of Fibroblasts and Blood in Patients With Rare Diseases · NA · not yet recruiting
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- NCT06521502 — The APS Phenotyping Study · recruiting
- NCT06373510 — Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration · NA · not yet recruiting
Other recruiting trials for Sepsis
Currently open trials in the same condition.
- NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other Abionic SA trials
Trials by the same sponsor.
- NCT05849935 — abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003 · completed
- NCT05596032 — Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 · completed
- NCT05627076 — Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Veno · completed
- NCT04442932 — abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies · withdrawn
- NCT04105699 — Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04409561 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abionic SA
- Last refreshed: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04409561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing