Feasibility StudyNCT06495775
Stool Sampling in the Acute Isolated Patient , Efficient Acquiring With a Novel Device
A study testing quickfact in people with Feasibility Study, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility Study
- What is being tested?
- quickfact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Nov 2021to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding Danish
- admitted to dept og oncology with diarrhea
- cognitive intact
- Co operable to fecal sampling
Who cannot join
- expected survival less than 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stool Sampling in the Acute Isolated Patient, Efficient Acquiring With a Novel Device
stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.
Read the detailed description
the stool sample device will be tested on all patients admitted to an oncological dept. on Zealand University Hospital, with diarrhea, in order to examine if the the device is feasabel and able to shorten time in isolation and time to relevant treatment.
- Conditions
- Feasibility Study
- Being tested
- quickfact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quickfactDevice
fecal sampling
| Study group | Role | What they receive |
|---|---|---|
| admitted patients | Experimental | fecal sampling Receives: Device: quickfact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stool Sample Acquired
instant acquiring of stool sample from acute admitted patients with diarrhea, the stool sample is collected bedside, and there after analysed with standard analysis for infectious pathogenes.
Measured: the sample is intended to be collected in an expected time range is within 1-2 hours after admission
Safety of Device
sampling with out harm to patient
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start26 Nov 2021
- Primary completion2 Jul 2024
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Feasibility StudyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Dorte b Krapper, Principal investigator, Oncological department, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495775
- Sponsor's protocol ID
- SJ-866
- Status last verified
- Jun 2024
- First submitted
- 5 May 2021
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Sampling in the Acute Isolated Patient, Efficient Acquiring With a Novel Device
- ClinicalTrials.gov ID
- NCT06495775
- Acronym / sponsor ID
- SJ-866
- Conditions
- Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.
Detailed description
the stool sample device will be tested on all patients admitted to an oncological dept. on Zealand University Hospital, with diarrhea, in order to examine if the the device is feasabel and able to shorten time in isolation and time to relevant treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| admitted patients | Experimental | Device: quickfactfecal sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understanding Danish
- admitted to dept og oncology with diarrhea
- cognitive intact
- Co operable to fecal sampling
Key exclusion criteria (1 listed)
- expected survival less than 2 weeks
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 |
|---|---|---|
| quickfactfecal sampling | Device | admitted patients |
Primary outcome
Number of Participants With Stool Sample Acquired
Time frame: the sample is intended to be collected in an expected time range is within 1-2 hours after admission
instant acquiring of stool sample from acute admitted patients with diarrhea, the stool sample is collected bedside, and there after analysed with standard analysis for infectious pathogenes.
Safety of Device
Time frame: 5 minutes
sampling with out harm to patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anne-Dorte b Krapper principal investigator
Oncological department, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quickfact in people with Feasibility Study, run by Zealand University Hospital at 1 site in Denmark.
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 4 inclusion and 1 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 30 Jan 2026. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Stool Sample Acquired (time frame: the sample is intended to be collected in an expected time range is within 1-2 hours after admission). The study lists 2 primary outcomes in all. 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 30 Jan 2026.