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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02512666
Other study ID # 15-070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 2017

Study information

Verified date June 2018
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AM4113-N5UT Dino-Lite


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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