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OpenTrials
Completed

NCT Number: NCT07317648

ClearSight NextGen1 Study

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

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York Teaching Hospitals NHS Foundation Trust

York, England, YO31 8HE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

ClearSight NextGen system

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

ClearSight NextGen System Clinical Development Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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