ClearSight NextGen1 Study

NCT ID: NCT07317648

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-16

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult OR patients with planned or existing arterial blood pressure monitoring

ClearSight NextGen system

Intervention Type DEVICE

Study devices will be applied to subjects for monitoring for the duration of the procedure.

Interventions

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ClearSight NextGen system

Study devices will be applied to subjects for monitoring for the duration of the procedure.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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York Teaching Hospitals NHS Foundation Trust

York, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Cristina Johnson

Role: CONTACT

949-308-5850

Other Identifiers

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2024-01

Identifier Type: -

Identifier Source: org_study_id

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