In Vivo Raman Spectroscopy of Human Capillary Beds



Status:Active, not recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:June 2017

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In Vivo Raman Spectroscopy (IVRS) of Human Fingertip Capillary Beds

The LighTouch device shines imperceptible red light into the skin and measures the light
that comes back out using the method of Raman Spectroscopy. Some of this light is color
shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines
the signals in this remitted light and calculates hematocrit, glucose, protein and
potentially other analytes. Thus the LighTouch device produces information without painful
physical insult to the patient and can trend changes in these blood analytes in order to
predict the need for intervention.

The leading preventable cause of death for all people between 18 and 45, world-wide,
military or civilian is uncontrolled internal bleeding i.e. hemorrhage. (A. Sauaia et al, J.
Trauma 38, 185-193 (1995)). Internal bleeding can be very difficult to reliably detect when
there is no visible external injury and the rate of blood loss is not very rapid. Two known
leading indicators of blood loss are fluctuations in hematocrit and blood protein
concentration. Monitoring of either of these analytes requires a blood draw and at least 3-5
minutes to obtain a single measurement. The LighTouch device shines imperceptible red light
into the skin and measures the light that comes back out using the method of Raman
Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary
numerical recipe, the LighTouch device combines the signals in this remitted light and
calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch
device produces information without painful physical insult to the patient and can trend
changes in these blood analytes in order to predict the need for intervention. Previous IRB
approved clinical trials over the last 10 years demonstrated useful performance for blood
glucose and now the hematocrit and protein analytes are ready to be tested. Since hematocrit
and protein concentrations change during hemodialysis it provides an ideal model to monitor
these fluctions over time and assess the precision and accuracy of the LighTouch device for
these analytes. This technique will not affect the usual dialysis treatment in any way. The
subject will place one finger into the machine for exposure to the incoming light signal and
sensors within the machine will detect light scatter from specfic analytes such as
hematocrit. Literally hundreds of individuals have experienced the LighTouch device since
1999 and there has never been an unpleasant response or adverse outcome. The system is
analagous to having a laser pointer shining on one's finger-tip. The ultimate goal of this
research is to develop the device into a reliable non-invasive measure of critical blood
elements that can be determined at the patient's side.

Inclusion Criteria:

- adult stable on dialysis and able to consent

Exclusion Criteria:

- inability to acquire IVRS signal
We found this trial at
1
site
Syracuse, New York 13210
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from
Syracuse, NY
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