NCT02206399

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

July 25, 2014

Last Update Submit

June 24, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Hemoglobin in Blood At Time of Test

    Up to 30 seconds

Eligibility Criteria

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

Whole Blood Donation Center Donors sample

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BloodSource

Sacramento, California, 95655-4128, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Anne Igbokwe, MD

    BloodSource

    PRINCIPAL INVESTIGATOR

  • Chris Gresens, MD

    BloodSource

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

August 1, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

US(1)