CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
INVSENSOR00001 +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03273166
NCT03273166N/ACompleted

Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution

Masimo Corporation·interventional·Posted Sep 6, 2017·Updated Oct 26, 2020

In Brief

A clinical study evaluating INVSENSOR00001, Control SpHb sensor, and 1 other intervention for Healthy. Completed, enrolled 82 participants across 1 site.

Detailed Summary

This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 6, 2017
Enrollment StartAug 29, 2017
Primary CompletionSep 18, 2017
TodayJul 2, 2026
Enrollment to primary: 19 daysPosted 8.8 years ago

Interventions

INVSENSOR00001device

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

Control SpHb sensordevice

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.

Hemodilutionprocedure

This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.