NCT07317648

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

November 21, 2025

Last Update Submit

April 3, 2026

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Data Collection for Development of ClearSight NextGen System

    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.

Study Arms (1)

Adult OR patients with planned or existing arterial blood pressure monitoring

EXPERIMENTAL
Device: ClearSight NextGen system

Interventions

ClearSight NextGen systemDEVICE

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

Adult OR patients with planned or existing arterial blood pressure monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York Teaching Hospitals NHS Foundation Trust

York, England, YO31 8HE, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 5, 2026

Study Start

October 16, 2025

Primary Completion

March 5, 2026

Study Completion

March 5, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)