Form, Fit, and Function of INVSENSOR00061

NCT05926648 | Completed Results FDA Device

• 1 other identifier: CIP-1077
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• INVSENSOR00061 SpO2 Accuracy

  The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n

  2 hours

Study Arms (1)

Test Subjects

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVENSOR00061

Device: INVSENSOR00061

Interventions

INVSENSOR00061 DEVICE

Noninvasive pulse oximetry and pulse rate device

Test Subjects

Eligibility Criteria

• Age: 0 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject is a full-term newborn (37 weeks) - up to 18 months of age.
• The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.

You may not qualify if:

• 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 has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 3, 2023
• Study Start: May 12, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Locations

US (1)