Non Invasive Optical Imaging of WBC Count

Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02512666

Enrollment

Registered

2015-07-31

Start date

2015-09-30

Completion date

2017-09-30

Last updated

2018-06-11

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

Conditions

Hematologic Malignancy

Keywords

Hematologic malignancy

Brief summary

This research study is looking at a small device that measures white blood cell (WBC) counts by being placed against the finger nail for participants who are undergoing stem cell transplantation at Massachusetts General Hospital or have a hematologic malignancy and are being seen as an outpatient.

Detailed description

The objective of this study is to obtain data that would support the use of a method to obtain WBC counts from images of small blood vessels called capillaries. These would be obtained by pressing a small device on the surface of participants' finger nails to look through the nail. These images will be obtained using a portable microscope called the Dino-Lite Digital Microscope. Having a non-invasive way to quickly measure WBC counts could be useful for a variety of healthcare applications.

Interventions

DEVICEAM4113-N5UT Dino-Lite

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic * Age ≥ 18 years * Ability to understand and the willingness to sign a written informed consent document. * Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.

Exclusion criteria

* History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil. * Myelodysplasia * Skin phototype \< 4 in the Fitzpatrick scale.

Design outcomes

Primary

Measure	Time frame	Description
Video of nail-fold imaging captured by capillaroscope	4 weeks	Image acquisition from device to then analyze and compare with complete blood counts measured in a standard fashion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026