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NCT03610269 · ClinicalTrials.gov registry record · NA

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

A NA study of Anemia, sponsored by Masimo Corporation.

Completed
Registry status
NA
Development phase
143
Enrollment target
1
Study location

NCT03610269: Completed NA study of Anemia, sponsored by Masimo Corporation.

NCT03610269 is a NA study of Anemia that has completed, run by Masimo Corporation. The registered enrollment target is 143 participants, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03610269, a NA study of Anemia, has completed, sponsored by Masimo Corporation.

COMPLETED
Registry status
NA
Development phase
143 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

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 diffe

Conditions Studied

Interventions

  • DEVICE INVSENSOR00026 (Pulse CO-Oximeter and sensor)

Study Locations (1)

California

  • Torrance Clinical Research - Lomita

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2018-08-01
Est. Completion 2018-08-16
Phase NA
Masimo Corporation

96 total trials

What the finished NCT03610269 record still lists

NCT03610269 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (66% lower).

The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 1 intervention - of which INVSENSOR00026 (Pulse CO-Oximeter and sensor) is the first listed.

NCT03610269 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT03610269 about?

NCT03610269 is a clinical study titled "Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026". 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).

What is the current status of trial NCT03610269?

This trial is currently completed. It is a NA study. The enrollment target is 143 participants. The study started on 2018-08-01. Estimated completion is 2018-08-16.

What conditions does trial NCT03610269 study?

This clinical trial studies the following conditions: Anemia.

What interventions are being tested in trial NCT03610269?

The interventions under investigation include: INVSENSOR00026 (Pulse CO-Oximeter and sensor) (DEVICE).

Who is sponsoring clinical trial NCT03610269?

This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03610269 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03610269's enrollment target sits among peer trials

143 40th of 72 higher than 33 of 72 other Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03610269, the US trial registry maintained by the National Library of Medicine. NCT03610269 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.