Form, Fit, and Function of INVSENSOR00061

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: INVSENSOR00061

Study type: Interventional

Funder types: Industry

Identifiers

NCT05926648

CIP-1077

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: Under 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

Test Subjects

Experimental group

Description:

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

Treatment:

Device: INVSENSOR00061