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SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

NCT ID: NCT05896267

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-06-22

Brief Summary

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This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.

Detailed Description

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Conditions

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Spo2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Masimo INVSENSOR00061

Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.

Group Type EXPERIMENTAL

Masimo INVSENSOR00061

Intervention Type DEVICE

Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )

Interventions

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Masimo INVSENSOR00061

Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Subject is a full-term newborn (37 weeks) to 18 months of age.

Exclusion Criteria

* • Subject has underdeveloped skin.

* Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
* Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
* Subject is not suitable for the investigation at the discretion of the Investigator.
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bailony Pediatrics

National City, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BAIL0003

Identifier Type: -

Identifier Source: org_study_id