Cardiac DiseaseNCT05581290
A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference
A study testing AI-Flex in people with Cardiac Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- AI-Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 17 Nov 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be referred for Cardiology Clinic Visit.
- Subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission
- Subject must be 18 - 85 years of age.
Who cannot join
- < 18 years of age or > 85 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference
The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.
- Conditions
- Cardiac Disease
- Being tested
- AI-Flex
- Keywords
- Underlying Cardiac Structural Condition
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-FlexDevice
A flexible multi-modal bio-sensing device with integrated AI capability used to measure ECG (heart's electrical activity), body temperature, and PPG (blood volume in tissue); primarly mounted on the wrist and chest.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Modal Sensor Patch Measurements | Experimental | Subjects referred to Mayo Clinic in Arizona Cardiology Clinic who have an underlying cardiac structural condition will have a 15-minute data collection via the prototype device, AI-Flex, and standard of care electrocardiogram (ECG), temperature, and photoplethysmogram (PPG) measurements. Receives: Device: AI-Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI-Flex ECG Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording
Measured: Baseline
AI-Flex Temperature Measurement Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement
Measured: Baseline
AI-Flex PPG Measurement Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start17 Nov 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imon Banerjee, Mayo Clinic
- Investigators
- Imon Banerjee, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581290
- Sponsor's protocol ID
- 22-005307
- Status last verified
- May 2024
- First submitted
- 12 Oct 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference
- ClinicalTrials.gov ID
- NCT05581290
- Acronym / sponsor ID
- 22-005307
- Conditions
- Cardiac Disease
- Keywords
- Underlying Cardiac Structural Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 14 Oct 2022 (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 purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal Sensor Patch Measurements | Experimental | Device: AI-FlexSubjects referred to Mayo Clinic in Arizona Cardiology Clinic who have an underlying cardiac structural condition will have a 15-minute data collection via the prototype device, AI-Flex, and standard of care electrocardiogram (ECG), temperature, and photoplethysmogram (PPG) measurements. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be referred for Cardiology Clinic Visit.
- Subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission
- Subject must be 18 - 85 years of age.
Key exclusion criteria (1 listed)
- < 18 years of age or > 85 years of age.
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 |
|---|---|---|
| AI-FlexA flexible multi-modal bio-sensing device with integrated AI capability used to measure ECG (heart's electrical activity), body temperature, and PPG (blood volume in tissue); primarly mounted on the wrist and chest. | Device | Multi-Modal Sensor Patch Measurements |
Primary outcome
AI-Flex ECG Accuracy
Time frame: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording
AI-Flex Temperature Measurement Accuracy
Time frame: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement
AI-Flex PPG Measurement Accuracy
Time frame: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement
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 23 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Imon Banerjee, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Flex in people with Cardiac Disease, run by Mayo Clinic 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 3 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: finished, as of the sponsor's last update on 23 May 2024. 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?
AI-Flex ECG Accuracy (time frame: Baseline). The study lists 3 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 23 May 2024.