ClearSight NextGen1 Study

April 3, 2026 updated by: Edwards Lifesciences

ClearSight NextGen System Clinical Development Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • York, England, United Kingdom, YO31 8HE
        • York Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Adult patients ≥ 18 years scheduled to undergo surgery with general anesthesia lasting >2 hours; with planned or existing monitoring with an arterial catheter as part of standard of care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult OR patients with planned or existing arterial blood pressure monitoring
Device: ClearSight NextGen system
Study devices will be applied to subjects for monitoring for the duration of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data Collection for Development of ClearSight NextGen System
Time Frame: Monitoring during surgery, for up to approximately 4 hours.
The objective of the study is to collect systolic and diastolic blood pressure data using the investigational CSNG system alongside CE-Marked ClearSight and FloTrac devices in adult subjects.
Monitoring during surgery, for up to approximately 4 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Actual)

March 5, 2026

Study Completion (Actual)

March 5, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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