ClinicalTrials.gg
CompletedNCT05849935AB-PSP-007Updated Aug 14, 2023

abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003

An observational study in Sepsis, sponsored by Abionic SA. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Abionic SA · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 517 studies in Sepsis with a site in United States — 75 open to participants now, 99 under way, 3 of them phase 3. Sepsis · United States.

Enrollment
148th of 204
61 · median 183
Started
2023
with 19 others
Observational
204 of 517
37 open now
Registered
435th of 517
by date

Among the 517 studies in Sepsis with a site in United States, this one is the 148th largest by enrollment of the 204 observational ones that give a count, is one of 20 that started in 2023, is one of 204 observational ones, and was the 435th 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

75 of the 517 studies in Sepsis with a site in United States are open now. Recruiting first, the newest first:

70 more — sign in →

All 75 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 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.

The full table on the hub →

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

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 517 studies in Sepsis with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Sepsis

Browse trials for

04

Who can participate

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

Study population

Adult healthy population

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. Renal disease
    2. Stoke
    3. Liver disease
    4. Pancreatic disease (including diabetes)
    5. AIDS
    6. Receiving antibiotic therapy
    7. Suspected infection
  2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
  3. Current diagnosis of uncontrolled diabetes.
  4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
  5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
  6. Diagnosis and/or treatment of cancer within the last 12 months.
  7. Received immunosuppressive therapy.
  8. Hospitalization for more than 24 hours within the last month.
  9. Reported as currently pregnant or nursing a child
  10. Unable or unwilling to provide the required blood sample for testing.
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.

05

Study design

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

Interventions

  • Diagnostic testabioSCOPE

    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.

06

What researchers measure

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.

    Time frame: through study completion, an average of 2 months

07

Study locations

1 site
  • Sundance Clinical
    Saint Louis, Missouri 63141, United States
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 Jul 2023 to primary completion in Jul 2023, 0 months.

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 0 months 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
Apr 28, 2023
First posted
May 9, 2023
StartActual
Jul 17, 2023
Primary completionActual
Jul 31, 2023
CompletionActual
Jul 31, 2023
Last update
Aug 14, 2023
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 Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05849935
Lead sponsor
Abionic SA
Collaborators
Avania
Responsible party
Sponsor
First posted
May 9, 2023
Start date
Jul 17, 2023
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Aug 14, 2023

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 Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion