ClinicalTrials.gg
CompletedNCT05627076Updated Nov 25, 2022

Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

An observational study in Sepsis and Sepsis Bacterial, sponsored by Abionic SA. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-25.

Sponsored by Abionic SA · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 208 studies in Sepsis with a site in France — 40 open to participants now, 45 under way, 5 of them phase 3. Sepsis · France.

Enrollment
79th of 97
46 · median 170
Started
2022
with 6 others
Observational
97 of 208
20 open now
Registered
159th of 208
by date

Among the 208 studies in Sepsis with a site in France, this one is the 79th largest by enrollment of the 97 observational ones that give a count, is one of 7 that started in 2022, is one of 97 observational ones, and was the 159th registered.

Sepsis

2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.

Browse Sepsis studies →

Open to participants now

40 of the 208 studies in Sepsis with a site in France are open now. Recruiting first, the newest first:

35 more — sign in →

All 40 open studies →

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

Who these studies take

Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

03

Conditions studied

  • Sepsis
  • Sepsis Bacterial

Browse trials for

Keywords

  • Abionic
  • Pancreatic Stone Protein
  • Point-of-care device
  • Immunoassay
  • IVD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients admitted at the hospital

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. Provide signed and dated written by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
  2. Male or female, 18 years of age or older;
  3. Patient admitted to hospital
  4. Need for venous and arterial blood samples as part of standard of care
  5. Covered by a social security scheme.

Exclusion criteria

Exclusion Criteria:

  1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
  2. Subject under juridical protection.
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No

Interventions

  • DeviceBlood Sampling

    Blood samples will be collected for the PSP measurement using the abioSCOPE.

06

What researchers measure

Primary outcomes

  1. Primary assessment

    Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.

    Time frame: through study completion, an average of 1.5 months

07

Study locations

1 site
  • CHU Limoges, Réanimation Polyvalente
    Limoges, 87042, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Aug 2022 to primary completion in Oct 2022, 1 month.

Of 52 industry-sponsored observational studies under Sepsis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 44. This study's 1 month is below that.

Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

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

Registered
Nov 10, 2022
First posted
Nov 25, 2022
StartActual
Aug 29, 2022
Primary completionActual
Oct 11, 2022
CompletionActual
Oct 31, 2022
Last update
Nov 25, 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 Nov 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05627076
Lead sponsor
Abionic SA
Responsible party
Sponsor
First posted
Nov 25, 2022
Start date
Aug 29, 2022
Primary completion
Oct 11, 2022
Completion
Oct 31, 2022
Last update
Nov 25, 2022

Oversight

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

Not currently enrolling

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

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Discussion

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