NCT06495775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

May 5, 2021

Results QC Date

December 9, 2025

Last Update Submit

January 29, 2026

Conditions

Feasibility Study

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

admitted patients

EXPERIMENTAL

fecal sampling

Device: quickfact

Interventions

quickfactDEVICE

fecal sampling

admitted patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understanding Danish
  • admitted to dept og oncology with diarrhea
  • cognitive intact
  • Co operable to fecal sampling

You may not qualify if:

  • expected survival less than 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

Location

Limitations and Caveats

none relevant

Results Point of Contact

Title
lasse bremholm hansen
Organization
zealand university, surgical dept
labha@regionsjaelland.dk
60927874

Study Officials

  • Anne-Dorte b Krapper

    Oncological department, Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

July 11, 2024

Study Start

November 26, 2021

Primary Completion

July 2, 2024

Study Completion

December 9, 2025

Last Updated

January 30, 2026

Results First Posted

January 30, 2026

Record last verified: 2024-06

Locations

DK(1)