NCT03128853

Brief Summary

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 31, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

15 days

First QC Date

April 14, 2017

Last Update Submit

April 22, 2020

Conditions

AnemiaHealthy

Outcome Measures

Primary Outcomes (1)

  • Repeatability and reproducibility of CO-oximeter and sensor

    The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.

    120 minutes

Study Arms (1)

Test subjects

EXPERIMENTAL

Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.

Device: Rad-67 and DCI Mini Sensor

Interventions

Rad-67 and DCI Mini SensorDEVICE
Test subjects

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age one month and older
  • Weight greater than or equal to 3 kg
  • The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

You may not qualify if:

  • Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
  • Decision-impaired adult on behalf of a pediatric patient who is unable to assent
  • Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
  • Subjects deemed not suitable for the study at the discretion of the investigator
  • Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Masimo Clinical Laboratory

Irvine, California, 92618, United States

Location

Site 1

Charlotte, North Carolina, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 25, 2017

Study Start

October 31, 2016

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

April 27, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)