ClearSight Baby Cuff

NCT06834516 | Completed FDA Device

• 1 other identifier: 2023-11
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

All study subjects

All study subjects will receive the ClearSight noninvasive finger cuff on one finger.

Device: ClearSight baby cuff

Interventions

ClearSight baby cuff DEVICE

Noninvasive device for continuous blood pressure monitoring

All study subjects

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Signed informed consent
• Age \< 2 years
• Availability of a standard blood pressure measurement as part of standard of care

You may not qualify if:

• Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
• Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
• Known sensitivities to system materials
• Broken or open skin located at the site of the finger cuff
• Proven left-right difference in blood pressure
• Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands, 1105AZ, Netherlands

Location

Study Officials

• Tina Abdelnour, MS, BSN

  Edwards Lifesciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 19, 2025
• Study Start: January 10, 2024
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)