NCT01915953

Brief Summary

The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 6, 2013

Status Verified

July 1, 2013

Enrollment Period

2.7 years

First QC Date

August 1, 2013

Last Update Submit

August 4, 2013

Conditions

Anemia

Keywords

Accurte Hb noninvasive measurement

Outcome Measures

Primary Outcomes (1)

  • compre the Hb values from the NBM200 series gainst the Hb from the lab blood analyser on Hematology pateints

    1 day

Study Arms (1)

anemia

Measuring Hb valuse on anemia patients

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hematology pateints

You may qualify if:

  • Participants aged 18 years and over

You may not qualify if:

  • Participants under the age of 18 years
  • Patients with significant deformity, degenerative changes or oedema of the fingers or hand
  • Patients with localized infection, ulceration or skin breaks involving the fingers
  • Patients with vascular disease or Raynaud's phenomenon affecting the fingers (vasospasm)
  • Participants who are unable to give informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Beer Yaacov, Israel, 70300, Israel

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Abraham Korenberg, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 5, 2013

Study Start

February 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

August 6, 2013

Record last verified: 2013-07

Locations

IL(1)