No Specific Conditions Are Being ExaminedNCT07775469
Comparison Study for Hemodynamic Parameters Generated by Vitalstream Relative to Appropriate Gold Standard References in Different Clinical Settings, (OR, EP Lab Etc.).
An observational study of No Specific Conditions Are Being Examined, run by CareTaker Medical LLC.
Trial summary
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Specific Conditions Are Being Examined
- What is being tested?
- Vitalstream
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Cooper Union Hospital patients receiving surgical, EP-Lab or Cath-Lab services
Who may be able to join
- Patients 18 years of age or older having the following surgery or procedures Electrophysiology Lab patients undergoing ablation Cardiac Catheterization Lab patients undergoing heart catheterization Cardiac Surgery patients including CABG and/or cardiac valve repair/replacement Abdominal Surgery patients including hepatectomy, pancreatectomy, and gastrectomy
Who cannot join
- Patients less than 18 years of age Patients with any pre-existing finger or hand injury which will preclude the placement of the Caretaker finger blood pressure cuff
About this study
Official title: Vitalstream Gold Standard Study
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard.
Read the detailed description
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard, either an arterial line or an upper arm cuff, to assess the capabilities and limitations of the technology. Specifically, the objective is to demonstrate the Vitalstream's ability to adhere to the limits prescribed by ANSI/AAMI/ISO 81060-2:2019 as closely as possible.
- Being tested
- Vitalstream
- Keywords
- Blood pressure comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalstreamDevice
Non-invasive BP monitoring. No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cooper Union patients | OR, ICU, EP-Lab, Cath-lab patients Receives: Device: Vitalstream |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP Reading Agreement
Measured: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
BP reading agreement according to ISO 81060 standard
Measured: 30 minutes to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion24 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific Conditions Are Being ExaminedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareTaker Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775469
- Sponsor's protocol ID
- Hemo_003
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitalstream Gold Standard Study
- ClinicalTrials.gov ID
- NCT07775469
- Acronym / sponsor ID
- Hemo_003
- Keywords
- Blood pressure comparison
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CareTaker Medical LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 20 Aug 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.
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard.
Detailed description
The goal of the proposed study is to test the capability of the Vitalstream monitor's continuous blood pressure tracking ability against Gold Standard, either an arterial line or an upper arm cuff, to assess the capabilities and limitations of the technology. Specifically, the objective is to demonstrate the Vitalstream's ability to adhere to the limits prescribed by ANSI/AAMI/ISO 81060-2:2019 as closely as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooper Union patients | – | Device: VitalstreamOR, ICU, EP-Lab, Cath-lab patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cooper Union Hospital patients receiving surgical, EP-Lab or Cath-Lab services
Key inclusion criteria (1 listed)
- Patients 18 years of age or older having the following surgery or procedures Electrophysiology Lab patients undergoing ablation Cardiac Catheterization Lab patients undergoing heart catheterization Cardiac Surgery patients including CABG and/or cardiac valve repair/replacement Abdominal Surgery patients including hepatectomy, pancreatectomy, and gastrectomy
Key exclusion criteria (1 listed)
- Patients less than 18 years of age Patients with any pre-existing finger or hand injury which will preclude the placement of the Caretaker finger blood pressure cuff
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 |
|---|---|---|
| VitalstreamNon-invasive BP monitoring. No intervention | Device | Cooper Union patients |
Primary outcome
BP Reading Agreement
Time frame: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
Time frame: 30 minutes to 24 hours
BP reading agreement according to ISO 81060 standard
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of No Specific Conditions Are Being Examined, run by CareTaker Medical LLC.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
BP Reading Agreement (time frame: 30 minutes to 24 hours). The study lists 2 primary outcomes in all. 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 20 Aug 2026.