Febrile IllnessNCT06056011
Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018
A study testing Connex CVSM with Timmy3 module in people with Febrile Illness, run by Baxter Healthcare Corporation at 5 sites in United States.
Trial summary
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018. Read more about this study
- Who is it for?
- Ages 1 day to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Febrile Illness
- What is being tested?
- Connex CVSM with Timmy3 module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Feb 2024to 18 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
- Subjects that are minors must provide assent to the clinical site's policy (if approved by Baxter) and/or the study sponsor's policy to participate in the study.
- Subject or the legally authorized representative (LAR) must sign the informed consent form in order for the subject to participate.
- Subject must be willing and able to comply with the study procedures.
- Age: normal weight (full-term) newborn to adult
- The study subject is in ambient temperature for at least 20 minutes prior to participating.
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- The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site.
- The study subject is not physically or emotionally agitated/uncooperative.
- The study subject or legal guardian speaks/understands fluent English.
Who cannot join
- Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
- The study subject has anatomical abnormalities that would affect temperature.
- The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
- The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
- The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
- The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.).
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- Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
- Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
- Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.
- Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
John R. Oishei Children's Hospital
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
Forest Lane Pediatrics
Dallas, Texas, 75230
First Georgia Physicians Group
Fayetteville, Georgia, 30214
Mankato Clinic
Mankato, Minnesota, 56001
About this study
Official title: TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
Read the detailed description
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.
- Conditions
- Febrile Illness
- Being tested
- Connex CVSM with Timmy3 module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connex CVSM with Timmy3 moduleDevice
Connex Vital Signs Monitor with the Timmy3 Investigational module
| Study group | Role | What they receive |
|---|---|---|
| Oral Temperature Measurement | Experimental | Febrile and non-febrile subjects aged 5 years or older. Receives: Device: Connex CVSM with Timmy3 module |
| Pediatric Axillary Temperature Measurement | Experimental | Febrile and non-febrile pediatric subjects <1 year to <18 years. Receives: Device: Connex CVSM with Timmy3 module |
| Adult Axillary Temperature Measurement | Experimental | Febrile and non-febrile adult subjects >= 18 years old. Receives: Device: Connex CVSM with Timmy3 module |
| Rectal Temperature Measurement | Experimental | Febrile and non-febrile adult and pediatric subjects newborn and older. Receives: Device: Connex CVSM with Timmy3 module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Measured: 20-30 minutes
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability
Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas [5] and [6]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability.
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Feb 2024
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Febrile IllnessStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Fernandez, M.D., Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056011
- Sponsor's protocol ID
- 60128116
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2023
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study
- ClinicalTrials.gov ID
- NCT06056011
- Acronym / sponsor ID
- 60128116
- Conditions
- Febrile Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 11 Mar 2026
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 document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
Detailed description
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Temperature Measurement | Experimental | Device: Connex CVSM with Timmy3 moduleFebrile and non-febrile subjects aged 5 years or older. |
| Pediatric Axillary Temperature Measurement | Experimental | Device: Connex CVSM with Timmy3 moduleFebrile and non-febrile pediatric subjects <1 year to <18 years. |
| Adult Axillary Temperature Measurement | Experimental | Device: Connex CVSM with Timmy3 moduleFebrile and non-febrile adult subjects >= 18 years old. |
| Rectal Temperature Measurement | Experimental | Device: Connex CVSM with Timmy3 moduleFebrile and non-febrile adult and pediatric subjects newborn and older. |
Who may qualify
- Ages
- 1 day to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
Key exclusion criteria (10 listed)
- Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
- Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.
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 |
|---|---|---|
| Connex CVSM with Timmy3 moduleConnex Vital Signs Monitor with the Timmy3 Investigational module | Device | Adult Axillary Temperature Measurement, Oral Temperature Measurement, Pediatric Axillary Temperature Measurement, Rectal Temperature Measurement |
Primary outcome
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias
Time frame: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement
Time frame: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability
Time frame: 20-30 minutes
Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas [5] and [6]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eric Fernandez, M.D. study director
Baxter Healthcare Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connex CVSM with Timmy3 module in people with Febrile Illness, run by Baxter Healthcare Corporation at 5 sites 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 9 inclusion and 10 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias (time frame: 20-30 minutes). The study lists 15 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 11 Mar 2026.