CHFNCT03463148
Validation of a Sensor for Non-Invasive Measurements
An observational study of CHF and Renal Disease, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
Subjects will be measured with both a sensor and a reference device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHF, Renal Disease, Hypertension
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 19 Apr 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Men and women over 22 years of age
Who may be able to join
- Subject is at least 18 (eighteen) years of age at screening.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject selection will not be based on age, height, or weight.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.
Who cannot join
- Subject is participating in another clinical study that may affect the results of either study.
- Subjects that are pregnant will not be included in the study.
- Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
- Subject is considered by the Principal Investigator to be medically unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
toSense, Inc. Headquarters
San Diego, California, 92121
About this study
Official title: Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms
Subjects will be measured with both a sensor and a reference device
Read the detailed description
Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.
- Conditions
- CHF, Renal Disease, Hypertension
- Medical subject headings
- Kidney Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Men/Women who meet the inclusion/exclusion criteria of this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. Specifically, Systolic Blood Pressure and Diastolic Blood Pressure with units of millimeters of mercury (mmHg) will be compared.
Measured: 3-36 Months
Fluids
Observation of fluid measurement from Sensor (ohms)
Measured: 3-36 Months
Heart Rate
Observation of heart rate measurement from Sensor (beats/min)
Measured: 3-36 Months
Heart Rate Variability
Observation of heart rate variability from Sensor (milliseconds)
Measured: 3-36 Months
Respiration Rate
Observation of respiration rate from Sensor (breaths/min)
Measured: 3-36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start24 Oct 2017
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHFStudies 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
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Banet, PhD, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463148
- Sponsor's protocol ID
- TS-IRB-0003
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2018
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms
- ClinicalTrials.gov ID
- NCT03463148
- Acronym / sponsor ID
- TS-IRB-0003
- Conditions
- CHF, Renal Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 13 Mar 2018 (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.
Subjects will be measured with both a sensor and a reference device
Detailed description
Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Men/Women who meet the inclusion/exclusion criteria of this protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women over 22 years of age
Key inclusion criteria (4 listed)
- Subject is at least 18 (eighteen) years of age at screening.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject selection will not be based on age, height, or weight.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.
Key exclusion criteria (4 listed)
- Subject is participating in another clinical study that may affect the results of either study.
- Subjects that are pregnant will not be included in the study.
- Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
- Subject is considered by the Principal Investigator to be medically unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
Time frame: 3-36 Months
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. Specifically, Systolic Blood Pressure and Diastolic Blood Pressure with units of millimeters of mercury (mmHg) will be compared.
Fluids
Time frame: 3-36 Months
Observation of fluid measurement from Sensor (ohms)
Heart Rate
Time frame: 3-36 Months
Observation of heart rate measurement from Sensor (beats/min)
Heart Rate Variability
Time frame: 3-36 Months
Observation of heart rate variability from Sensor (milliseconds)
Respiration Rate
Time frame: 3-36 Months
Observation of respiration rate from Sensor (breaths/min)
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 20 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Matthew Banet, PhD principal investigator
Baxter Healthcare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHF and Renal Disease, run by Baxter Healthcare Corporation at 1 site in United States.
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 4 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 20 Jan 2022. 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 States. 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?
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. (time frame: 3-36 Months). The study lists 5 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 Jan 2022.