In Vivo Raman Spectroscopy of Human Capillary Beds

Anemia Clinical Trial

— IVRS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02333136
• Other study ID #: 327074-1
• Status: Terminated
• Start date: August 2012
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2024
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult stable on dialysis and able to consent

Exclusion Criteria:

• inability to acquire IVRS signal

Related Conditions & MeSH terms

• Anemia

Intervention

Device:
• raman spectroscopy (LighTouch)
near infrared light will be shone upon a fingerbed capillary and light scatter measured using in vivo raman spectroscpy

Locations

Country	Name	City	State
United States	University Dialsyis Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation with actual measured hematocrit		2 hours during dialysis