ClinicalTrials.gg
CompletedNCT04409561Updated Mar 2, 2022

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

An observational study in Sepsis, Septic Shock and Healthy, sponsored by Abionic SA. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Abionic SA · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 164 studies in Shock, Septic with a site in United States — 19 open to participants now, 26 under way, 1 of them phase 3. Shock, Septic · United States.

Enrollment
28th of 47
150 · median 330
Started
2021
with 7 others
Observational
47 of 164
6 open now
Registered
123rd of 164
by date

Among the 164 studies in Shock, Septic with a site in United States, this one is the 28th largest by enrollment of the 47 observational ones that give a count, is one of 8 that started in 2021, is one of 47 observational ones, and was the 123rd registered.

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

Browse Shock, Septic studies →

Open to participants now

19 of the 164 studies in Shock, Septic with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 164 studies in Shock, Septic with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Sepsis
  • Septic Shock
  • Healthy

Browse trials for

Keywords

  • Sepsis
  • Pancreatic Stone Protein
  • Immunoassay
  • Abionic
  • Healthy population
  • Point-of-care device
04

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 150 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Abionic SA is the lead sponsor of 8 studies on the registry; none are open to participants now.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

150 generally healthy adults. This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:
  1. Heart disease
  2. Stroke
  3. Renal disease
  4. Liver disease
  5. Pancreatic disease
  6. Chronic obstructive pulmonary disorder
  7. Bleeding disorders
  8. Hypercalcitoninemia
  9. AIDS
  10. Receiving antibiotic therapy
  11. Suspected infection
    1. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
    1. Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.
    1. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.

    5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care.

    1. Current diagnosis of cancer within the last 12 months.
    1. Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.
    1. Hospitalization for more than 24 hours within the last 3 months.
    1. Reported as currently pregnant or nursing a child
    1. Unable or unwilling to provide the required blood sample for testing.
    1. Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Interventions

    This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.

    Device: Blood collection

Interventions

  • DeviceBlood collection

    9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

07

What researchers measure

Primary outcomes

  1. Determination of reference range interval of PSP

    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: Day 1

Secondary outcomes

  1. Collect medical data of healthy volunteer

    To collect medical data from the 150 study participants using a volunteer questionnaire

    Time frame: Day 1

  2. Obtain well characterised samples library to be used for future tests development

    Whole blood collection from 150 healthy subject to be used for future tests development.

    Time frame: Day 1

08

Study locations

1 site
  • Mercy Health St. Vincent
    Toledo, Ohio 43608, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Nov 2021, 0 months.

Of 201 observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2020
First posted
Jun 1, 2020
StartActual
Nov 15, 2021
Primary completionActual
Nov 15, 2021
CompletionActual
Jan 15, 2022
Last update
Mar 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04409561
Lead sponsor
Abionic SA
Collaborators
Boston Biomedical Associates, Ocean State Clinical Coordinating Center
Responsible party
Sponsor
First posted
Jun 1, 2020
Start date
Nov 15, 2021
Primary completion
Nov 15, 2021
Completion
Jan 15, 2022
Last update
Mar 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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