Non-Invasive Hemoglobin Study

Non-Invasive Hemoglobin Multi-Center Observational Study

The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.

Study Overview

• Status: Completed
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Actual): 237

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95655-4128
      • BloodSource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Whole Blood Donation Center Donors sample

Description

Inclusion criteria for this study are:

1. Subject is capable of giving informed consent.
2. Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device.

Exclusion criteria for this study are:

1. Age less than 18 years at time of research
2. Subject lacks the digits to place in the POCT device
3. Subject displays symptoms or has a history of Raynaud's disease
4. Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec.
5. Subject has a history of long term continuous decreased perfusion to either hand (>30 days).
6. Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study
7. Subject's same day participation in this study
8. Capillary sample volume is not adequate to complete testing on the comparative device.
9. Cold agglutinin disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Hemoglobin in Blood At Time of Test	Up to 30 seconds

Collaborators and Investigators

• Sponsor: Convergence Biometrics
• Collaborators: DRMiller Engineering
• Investigators: Principal Investigator: Anne Igbokwe, MD, BloodSource; Principal Investigator: Chris Gresens, MD, BloodSource

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BLS-1