NCT03610269

Brief Summary

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

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 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 25, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

15 days

First QC Date

July 26, 2018

Results QC Date

April 19, 2019

Last Update Submit

June 5, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation

    Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

    Up to 2 hours per subject

Study Arms (1)

INVSENSOR00026

EXPERIMENTAL

All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).

Device: INVSENSOR00026 (Pulse CO-Oximeter and sensor)

Interventions

INVSENSOR00026 (Pulse CO-Oximeter and sensor)DEVICE

Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)

INVSENSOR00026

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Subject has given written informed consent to participate in the study

You may not qualify if:

  • (\*) Pregnant or positive human chorionic gonadotropin (hCG) test
  • (\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
  • (\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
  • (\*) Subjects who are currently taking anticoagulant medication
  • (\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
  • (\*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
  • (\*) 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.
  • (\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
  • (\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
  • Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff
  • Note: (\*) May be self-reported by subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torrance Clinical Research

Lomita, California, 90717, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Vikram Ramakanth
Organization
Masimo
clinicalresearchdept@masimo.com
949-297-7416

Publication Agreements

PI is Sponsor Employee
Yes

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

July 26, 2018

First Posted

August 1, 2018

Study Start

August 1, 2018

Primary Completion

August 16, 2018

Study Completion

August 16, 2018

Last Updated

June 25, 2019

Results First Posted

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)