Clinical investigation to demonstrate the safety and performance of FIDscreen - an optical diagnostic device for the non-invasive measurement of the zinc-protoporphyrin IX / heme ratio

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035711

Enrollment

185

Registered

2025-03-05

Start date

2025-05-19

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

E61.1

Interventions

Group 1: The clinical trial is designed as prospective, single arm, non-blinded, monocentric study on ambulant or hospitalized patients presenting in the nephrology department for dialysis, apheresis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Written patient consent after comprehensive information - Age = 18 years - Routine blood withdrawal on same day as measurement with FIDscreen device

Exclusion criteria

Exclusion criteria: - Subject is not able or not willing to sign the informed consent - Known pregnancy - Breastfeeding woman

Design outcomes

Primary

Measure	Time frame
Safety of FIDscreen is deemed successfully shown if no device-related serious adverse events occur during the measurement. Performance of FIDscreen is deemed successfully shown if the robust Limits of Agreement delivered by FIDscreen versus the reference method for the 135 patients of the validation phase are smaller than 25 µmol / mol heme with a confidence of 95%. As further performance parameter, the robust coefficient of variation of repeated measurements on the same subject shall be determined.	—

Measure

Time frame

Safety of FIDscreen is deemed successfully shown if no device-related serious adverse events occur during the measurement. Performance of FIDscreen is deemed successfully shown if the robust Limits of Agreement delivered by FIDscreen versus the reference method for the 135 patients of the validation phase are smaller than 25 µmol / mol heme with a confidence of 95%. As further performance parameter, the robust coefficient of variation of repeated measurements on the same subject shall be determined.

—

Secondary

Measure	Time frame
Comparison of the zinc protoporphyrin IX / heme ratio with other biomarkers of iron deficiency (Ferritin, Transferrin saturation, soluble Transferrin receptor).	—

Countries

Germany

Contacts

Public ContactChristian Homann

FerroSens GmbH

c.homann@ferrosens.de+49 89 9274 2705

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026