Skip to content

Qualification and application of the HemoScreen hematology analyzer for point-of-care diagnostics in a hematology-oncology patient population

Qualification and application of the HemoScreen hematology analyzer for point-of-care diagnostics in a hematology-oncology patient population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039233
Enrollment
80
Registered
2026-02-17
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Point-of-care diagnosis of hematological parameters using the HemoScreen device in a hematological-oncological patient population

Interventions

Group 1: Qualification: Evaluation of the accuracy of complete blood count parameters measured using the point-of-care testing system (HemoScreen) from capillary blood in patients with hematological m

Sponsors

Universitätsklinikum Jena
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with hematological-oncological diseases undergoing chemotherapy

Exclusion criteria

Exclusion criteria: No possibility of capillary blood sampling from the fingertip

Design outcomes

Primary

MeasureTime frame
Qualification: Measurements of complete blood count parameters using HemoScreen (capillary blood sample) and Sysmex XN (venous blood sample). Mobile laboratory: Implementation of the HemoScreen system for measurements in the patient's home environment. Prediction model: Development of an AI-supported prediction model.

Secondary

MeasureTime frame
Qualification: Comparison of blood values measured with the HemoScreen system with the reference values of the Sysmex XN. Determination of measurement accuracy (correlation coefficient, bias) according to predefined deviation limits. Mobile laboratory: Evaluation of point-of-care complete blood count measurements and patient questionnaires. Prediction model: Validation of the prediction model.

Countries

Germany

Contacts

Public ContactMichael Kiehntopf

Universitätsklinikum Jena

michael.kiehntopf@med.uni-jena.de+49 3641 9325000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026