Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

15-070


NCT ID:

NCT02512666


Secondary ID:


Study Acronym:


Brief Title:

Non Invasive Optical Imaging of WBC Count


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Actual


Overall Contact Information

Official Name:Yi-Bin A Chen, MD
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:September 2015
Completion Date:September 2017
Completion Type:Actual
Primary Completion Date:September 2017
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 7, 2018
First Received Date:July 28, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Device
Name:AM4113-N5UT Dino-Lite
Arm Name:Non-Invasive Imaging

Study Arms

Study Arm Type:Experimental
Arm Name:Non-Invasive Imaging
Description:Commercial portable optical microscope (AM4113-N5UT Dino-Lite ) which will be employed during the study for a pre determined time of non-invasive imaging of the nailfold capillaries in ASCT patients. For Autologous Stem Cell Transplant (ASCT) participants, the imaging will be performed once prior to ASCT upon admission to the hospital, and then daily after ASCT (starting on day +7) until count recovery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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