Non-Invasive Hemoglobin Study

Anemia Clinical Trial

Official title:

Non-Invasive Hemoglobin Multi-Center Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206399
• Other study ID #: BLS-1
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: June 24, 2016
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: June 2016
• Source: Convergence Biometrics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration and Office for Human Research Protections
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
United States	BloodSource	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Convergence Biometrics	DRMiller Engineering

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Hemoglobin in Blood At Time of Test		Up to 30 seconds	No