NCT02333136

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

11.4 years

First QC Date

November 25, 2014

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlation with actual measured hematocrit

    2 hours during dialysis

Study Arms (1)

IVRS studied

subjects will be monitored for changes in hematocrit based on results of in vivo raman spectroscopy scatter

Device: raman spectroscopy (LighTouch)

Interventions

near infrared light will be shone upon a fingerbed capillary and light scatter measured using in vivo raman spectroscpy

IVRS studied

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stabel dialysis patients

You may qualify if:

  • adult stable on dialysis and able to consent

You may not qualify if:

  • inability to acquire IVRS signal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Dialsyis Center

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Spectrum Analysis, Raman

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Scattering, RadiationChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Joseph Chaiken, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

January 7, 2015

Study Start

August 1, 2012

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations