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stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| admitted patients | Experimental | fecal sampling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quickfact | Device | fecal sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Dorte b Krapper | Oncological department, Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Roskilde | Region Sjælland | 4000 | Denmark |
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all 50 participants was recruited succes fully and in rolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Admitted Patients | fecal sampling, instant attempt of acquiring of stool sample from acute admitted patients with diarrhea with the novel device, the stool sample is collected bedside, and if an stool sample is acquired it is there after analysed with standard analysis for infectious pathogenes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Admitted Patients | fecal sampling, instant attempt of acquiring of stool sample from acute admitted patients with diarrhea with the novel device, the stool sample is collected bedside, and if an stool sample is acquired it is there after analysed with standard analysis for infectious pathogenes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | the sample is intended to be collected in an expected time range is within 1-2 hours after admission |
|
|
from enrollment til end of follow up, up to 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Admitted Patients | fecal sampling, 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. |
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none relevant
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| lasse bremholm hansen | zealand university, surgical dept | 60927874 | labha@regionsjaelland.dk |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2022 | Jan 10, 2026 | Prot_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Number of Participants With Stool Sample Acquired and Analyzed | sufficient amount of stool aqquired for a stool sample to be analysed | Number | Number of Participants With Stool Sample |
|
| Participants |
|
|
| Primary | Safety of Device | sampling with out harm to patient | Posted | Count of Participants | Participants | 5 minutes |
|
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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