Blood PressureNCT05790265
Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese Pregnant Women
A study testing ANNE One in people with Blood Pressure, run by Sibel Health Inc..
Trial summary
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor \& Delivery (L\&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ANNE One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Ability and willingness to provide written informed consent
- Admitted for delivery at UNC Medical Center
- BMI of >= 40 kg/m2
- Clinically indicated radial A-lines either planned or already in-situ prior to delivery
Who cannot join
- Skin sensitivity or allergy that precludes placement of ANNE One
- Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation
- Expected delivery within <= 1 hour of arrival to L\&D
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese and Super-obese Pregnant Women
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor \& Delivery (L\&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.
- Conditions
- Blood Pressure
- Being tested
- ANNE One
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE OneDevice
Chest sensor for single lead ECG and finger sensor for pulse oximetry.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of ANNE One system blood pressure measurements to arterial line | Experimental | Not described Receives: Device: ANNE One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line
Mean absolute error and standard deviation between the non-invasive blood pressure measurement provided by the device under test and the invasive blood pressure measurement from the arterial line.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibel Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790265
- Sponsor's protocol ID
- 22-2375
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese and Super-obese Pregnant Women
- ClinicalTrials.gov ID
- NCT05790265
- Acronym / sponsor ID
- 22-2375
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sibel Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Mar 2023 (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.
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor \& Delivery (L\&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of ANNE One system blood pressure measurements to arterial line | Experimental | Device: ANNE One |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years old
- Ability and willingness to provide written informed consent
- Admitted for delivery at UNC Medical Center
- BMI of >= 40 kg/m2
- Clinically indicated radial A-lines either planned or already in-situ prior to delivery
Key exclusion criteria (3 listed)
- Skin sensitivity or allergy that precludes placement of ANNE One
- Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation
- Expected delivery within <= 1 hour of arrival to L\&D
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 |
|---|---|---|
| ANNE OneChest sensor for single lead ECG and finger sensor for pulse oximetry. | Device | Comparison of ANNE One system blood pressure measurements to arterial line |
Primary outcome
Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line
Time frame: 8 hours
Mean absolute error and standard deviation between the non-invasive blood pressure measurement provided by the device under test and the invasive blood pressure measurement from the arterial line.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ANNE One in people with Blood Pressure, run by Sibel Health Inc..
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah E Coughlin ((224)251-8859, sarah.coughlin@sibelhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line (time frame: 8 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 30 Mar 2023.