An interventional study of AM4113-N5UT Dino-Lite in Hematologic Malignancy, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Device feasibility
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
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
Device: AM4113-N5UT Dino-Lite
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
Time frame: 4 weeks
Plan to share: No — No plan to share data
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital