CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Rainbow DCI and R1-25 sensordevice
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/NCT03157232
NCT03157232N/ACompleted
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Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

Masimo Corporation·interventional·Posted May 17, 2017·Updated Jul 27, 2017

In Brief

A clinical study evaluating Rainbow DCI and R1-25 sensor for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.

Study Details

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

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartJun 19, 2009
Primary CompletionJun 29, 2009
TodayJul 2, 2026
Enrollment to primary: 10 daysPosted 9.1 years ago

Interventions

Rainbow DCI and R1-25 sensordevice

Noninvasive Measurement of SpHb