RecruitingNCT07317648
ClearSight NextGen1 Study
ClearSight NextGen System Clinical Development Study
Sponsor
Edwards Lifesciences
Enrollment
30 participants
Start Date
Oct 16, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Signed informed consent
- Age ≥ 18 years
- Planned or existing monitoring with an arterial catheter as part of standard of care
- Patient scheduled to undergo surgery with general anesthesia lasting > 2 hours
Exclusion Criteria8
- Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the study finger cuffs
- Known left-right difference in blood pressure
- 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
- Patients deemed not suitable for the study at the discretion of the Investigator
- Participation in another study that clinically interferes with the current study
- Treatment with an intra-aortic balloon pump
- Pregnancy
- Cardiac surgery including bypass period
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Interventions
DEVICEClearSight NextGen system
Study devices will be applied to subjects for monitoring for the duration of the procedure.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07317648
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