ClearSight NextGen1 Study

Edwards Lifesciences

Status: Enrolling

Conditions: Blood Pressure

Treatments: Device: ClearSight NextGen system

Study type: Observational

Funder types: Industry

Identifiers

NCT07317648

2024-01

Details and patient eligibility

About

A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. Age ≥ 18 years
3. Planned or existing monitoring with an arterial catheter as part of standard of care
4. Patient scheduled to undergo surgery with general anesthesia lasting > 2 hours

Exclusion criteria

1. Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the study finger cuffs
2. Known left-right difference in blood pressure
3. 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
4. Patients deemed not suitable for the study at the discretion of the Investigator
5. Participation in another study that clinically interferes with the current study
6. Treatment with an intra-aortic balloon pump
7. Pregnancy
8. Cardiac surgery including bypass period

Trial design

30 participants in 1 patient group

Adult OR patients with planned or existing arterial blood pressure monitoring

Treatment:

Device: ClearSight NextGen system