Evaluation of blood volume, test values, and pain for automatic blood collection device from fingers using single-use automatic lancet (medical equipment)

Basic evaluation of automated blood sampling by finger-prick

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042200104

Enrollment

200

Registered

2021-03-03

Start date

2021-03-03

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Healthy Volunteers

Interventions

Blood sample collection

Capillary blood sampling by finger-prick ( 2 times) , upper arm (elbow) Vein Blood collection (1 time)

D001800

Blood collection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Persons who apply for this study, after receiving a sufficient explanation of the study, provide the consent of the document based on their own free will. 2. Those selected by the research director or research contributor in consideration of reducing bias in the age group and gender.

Exclusion criteria

Exclusion criteria: 1. Person who did not provide a document consent based on free will of the person 2. Person deemed inappropriate by the research director

Design outcomes

Primary

Measure	Time frame
1) Blood collection volume For all cases, blood collection volumes with the prototype device should be recorded as follows, considering target volume and time. The target volume and time is 250 uL in 90 seconds for complete blood count tests, and 400 uL in 150 seconds for biochemistry and immunoassay tests. - Complete blood count; Time at 250uL collected (time less than 90 seconds), Volume at 90 seconds (volume less than 250uL) - Biochemistry and Immunoassay; Time at 400uL collected (time less than 150 seconds), Volume at 150 seconds (volume less than 400uL) In addition, using fiber cameras built into the prototype device, changes of blood volume in a micro blood collection tube and changes of bleeding from the fingertip are recorded in the video. This video is used to evaluate the time variation of the bleeding speed. 2) Measured values of the test items The same test items of the fingertip blood and of the venous blood are measured with the same instruments and the same reagents. The results are to be evaluated in variation, correlation, and deviation points of view. 3) Pain The research subjects assess the pain of the fingertip blood collection in 0-10 degrees by questionnaire. The degree of pain is compared with that of the upper arm (elbow) vein puncture.	—

Measure

Time frame

1) Blood collection volume For all cases, blood collection volumes with the prototype device should be recorded as follows, considering target volume and time. The target volume and time is 250 uL in 90 seconds for complete blood count tests, and 400 uL in 150 seconds for biochemistry and immunoassay tests. - Complete blood count; Time at 250uL collected (time less than 90 seconds), Volume at 90 seconds (volume less than 250uL) - Biochemistry and Immunoassay; Time at 400uL collected (time less than 150 seconds), Volume at 150 seconds (volume less than 400uL) In addition, using fiber cameras built into the prototype device, changes of blood volume in a micro blood collection tube and changes of bleeding from the fingertip are recorded in the video. This video is used to evaluate the time variation of the bleeding speed. 2) Measured values of the test items The same test items of the fingertip blood and of the venous blood are measured with the same instruments and the same reagents. The results are to be evaluated in variation, correlation, and deviation points of view. 3) Pain The research subjects assess the pain of the fingertip blood collection in 0-10 degrees by questionnaire. The degree of pain is compared with that of the upper arm (elbow) vein puncture.

—

Secondary

Measure	Time frame
4)Relationships between the blood volumes collected from fingertips and the fingertip vascular images - Relationships between the collected blood volumes and the prick positions in the fingertip vascular images - Common characteristics in the fingertip vascular images of the research subjects who can collect larger (or smaller) blood volumes from fingertips	—

Contacts

Public ContactTakashi Irie

Hitachi High-Tech Corporation

takashi.irie.jw@hitachi-hightech.com+81-80-1352-7922

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026