ClearSight Baby Cuff

Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: ClearSight baby cuff

Detailed Description

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Amsterdam UMC, location AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be less than 2 years of age with blood pressure monitoring as part of routine care.

Description

Inclusion Criteria:

1. Signed informed consent
2. Age < 2 years
3. Availability of a standard blood pressure measurement as part of standard of care

Exclusion Criteria:

1. Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
2. Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
3. Known sensitivities to system materials
4. Broken or open skin located at the site of the finger cuff
5. Proven left-right difference in blood pressure
6. Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
7. Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All study subjects; All study subjects will receive the ClearSight noninvasive finger cuff on one finger.	Device: ClearSight baby cuff; Noninvasive device for continuous blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proper cuff fit	The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.	30 minutes of monitoring with study devices during scheduled surgery procedure
Cuff remains properly fitted for the duration of the study measurement	The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants.	30 minutes of monitoring with study devices during scheduled surgery procedure
Measurement with monitor started without errors	A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction.	30 minutes of monitoring with study devices during scheduled surgery procedure
Measurement stability within 10 mins	The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction.	30 minutes of monitoring with study devices during scheduled surgery procedure
Early feasibility accuracy	For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg.	30 minutes of monitoring with study devices during scheduled surgery procedure

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Study Director: Tina Abdelnour, MS, BSN, Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes