Blood PressureNCT07317648
ClearSight NextGen1 Study
A study testing ClearSight NextGen system in people with Blood Pressure, run by Becton, Dickinson and Company at 1 site in United Kingdom.
Trial summary
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ClearSight NextGen system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
York Teaching Hospitals NHS Foundation Trust
York, England, YO31 8HE
About this study
Official title: ClearSight NextGen System Clinical Development Study
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.
- Conditions
- Blood Pressure
- Being tested
- ClearSight NextGen system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSight NextGen systemDevice
Study devices will be applied to subjects for monitoring for the duration of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Adult OR patients with planned or existing arterial blood pressure monitoring | Experimental | Not described Receives: Device: ClearSight NextGen system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monitoring during surgery, for up to approximately 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start16 Oct 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317648
- Sponsor's protocol ID
- 2024-01
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClearSight NextGen System Clinical Development Study
- ClinicalTrials.gov ID
- NCT07317648
- Acronym / sponsor ID
- 2024-01
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult OR patients with planned or existing arterial blood pressure monitoring | Experimental | Device: ClearSight NextGen system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearSight NextGen systemStudy devices will be applied to subjects for monitoring for the duration of the procedure. | Device | Adult OR patients with planned or existing arterial blood pressure monitoring |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Not yet recruiting
A MOST Framework Trial Evaluating the MOst effectiVe Exercise Types for Blood Pressure Control
Hypertension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Assessing Blood Pressure Variability in a Healthy Adult Population During Transcutaneous Hypoglossal Nerve Stimulation With the Zeus Sleep Device
Transcutaneous Hypoglossal Nerve Stimulation
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearSight NextGen system in people with Blood Pressure, run by Becton, Dickinson and Company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection for Development of ClearSight NextGen System (time frame: Monitoring during surgery, for up to approximately 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.