SepsisNCT04409561
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
An observational study of Sepsis and Septic Shock, run by Abionic SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Healthy
- What is being tested?
- Blood collection
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 15 Jan 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Male or female, aged ≥ 18 years.
- Apparently healthy as determined by a subject questionnaire.
Who cannot join
- 1) Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:
- Heart disease
- Stroke
- Renal disease
- Liver disease
- Pancreatic disease
Show all 23Show fewer
- Chronic obstructive pulmonary disorder
- Bleeding disorders
- Hypercalcitoninemia
- HIV AIDS
- Receiving antibiotic therapy
- Suspected infection
- Immunosuppression
- 2) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
- 3) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.
- 4) 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.
- 6) Current diagnosis of cancer within the last 12 months.
- 7) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.
- 8) Hospitalization for more than 24 hours within the last 3 months.
- 9) Reported as currently pregnant or nursing a child
- 10) Unable or unwilling to provide the required blood sample for testing.
- 11) Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
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.
- Conditions
- Sepsis, Septic Shock, Healthy
- Being tested
- Blood collection
- Keywords
- Sepsis, Pancreatic Stone Protein, Immunoassay, Abionic, Healthy population, Point-of-care device
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Collect medical data of healthy volunteer
To collect medical data from the 150 study participants using a volunteer questionnaire
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start15 Nov 2021
- Primary completion15 Nov 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abionic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Biomedical Associates, Ocean State Clinical Coordinating Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409561
- Sponsor's protocol ID
- AB-PSP-003
- Status last verified
- Feb 2022
- First submitted
- 14 May 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
- ClinicalTrials.gov ID
- NCT04409561
- Acronym / sponsor ID
- AB-PSP-003
- Conditions
- Sepsis, Septic Shock, Healthy
- Keywords
- Sepsis, Pancreatic Stone Protein, Immunoassay, Abionic, Healthy population, Point-of-care device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Abionic SAIndustry (pharma, biotech, devices)
- Collaborators
- Boston Biomedical Associates, Ocean State Clinical Coordinating Center
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | – | Device: Blood collectionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female, aged ≥ 18 years.
- Apparently healthy as determined by a subject questionnaire.
Key exclusion criteria (23 listed)
- 1) Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:
- Heart disease
- Stroke
- Renal disease
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection9 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 | Device | Interventions |
Primary outcome
Determination of reference range interval of PSP
Time frame: Day 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.
2 secondary outcomes
Collect medical data of healthy volunteer
Time frame: Day 1
Obtain well characterised samples library to be used for future tests development
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Abionic SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of reference range interval of PSP (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.