ClearSight Baby Cuff

Edwards Lifesciences

Status: Completed

Conditions: Blood Pressure

Treatments: Device: ClearSight baby cuff

Study type: Observational

Funder types: Industry

Identifiers

NCT06834516

2023-11

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

All study subjects

Description:

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

Treatment:

Device: ClearSight baby cuff