ClinicalTrials.gov record

Completed Not applicable Interventional Accepts healthy volunteers Results available

Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo

ClinicalTrials.gov ID: NCT05674136

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 80601-2-61 standard which is also adopted and referenced by the FDA.

Study identification

NCT ID: NCT05674136
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Masimo Corporation; Industry
Enrollment: 62 participants

Conditions and interventions

Conditions

Healthy

Interventions

INVSENSOR00061 Device

Device

Eligibility (public fields only)

Age range: 18 Years to 50 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 18, 2022 (Actual)
Primary completion: Dec 7, 2022 (Actual)
Completion: Dec 7, 2022 (Actual)
Last update posted: Jun 13, 2024

2022

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Masimo Corporation	Irvine	California	92618	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05674136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 13, 2024 · Synced Nov 15, 2026