FebrileNCT04727801
A Clinical Data Collection Study of Verily Patch
An observational study of Febrile and Afebrile, run by Verily Life Sciences LLC at 1 site in United States.
Trial summary
This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Verily Patch
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2021to 25 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 participants (50 febrile and 50 afebrile) will be enrolled at one investigational site. Febrile is defined as having sublingual temperatures of 37.50C or above. Participants that exhibit COVID-19 symptoms and/or COVID-19 diagnosis may be included in the study.
Who may be able to join
- At least 18 years old
- Able to read and speak English
- Able to read and understand the Informed Consent Form
- Willing to wear Verily Patch in the axillary region
- Willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings
- Have a working smartphone device and willing to use it for study activities
- Willing to install study apps on their personal smartphone
- Willing to comply with all study-related procedures
Who cannot join
- Pregnant or breastfeeding during study participation
- Have known allergies to medical grade adhesives
- Have known cutaneous hypersensitivity
- Have infection in both axilla
- Have open injury or rash where the study device will be worn
- Have a cardiac pacemaker or other implanted electronic medical device(s)
- Have any additional condition or situation that, in the opinion of the investigator, makes the subject inappropriate for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.
- Being tested
- Verily Patch
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verily PatchDevice
The Verily Patch is an investigational wearable temperature sensor that consists of a Patch (Verily Patch), with swappable adhesives, as well as an app (Verily Patch app).
| Study group | Role | What they receive |
|---|---|---|
| Febrile (n=50) | Febrile is defined as having sublingual temperatures of 37.5 °C or above. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. Receives: Device: Verily Patch | |
| Afebrile (n=50) | Afebrile is defined as having sublingual temperatures of less than 37.5 °C. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. Receives: Device: Verily Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection to support development activities for Verily Patch
Data collection to enable device development of the Verily Patch, which includes the development of an algorithm that estimates temperature
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start11 Mar 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Why it stopped: Decision by the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FebrileStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Marks, MD, Study director, Verily Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727801
- Sponsor's protocol ID
- 102782
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2021
- Last updated
- 20 Aug 2021
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Data Collection Study of Verily Patch
- ClinicalTrials.gov ID
- NCT04727801
- Acronym / sponsor ID
- 102782
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision by the Sponsor
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 27 Jan 2021 (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 is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febrile (n=50) | – | Device: Verily PatchFebrile is defined as having sublingual temperatures of 37.5 °C or above. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. |
| Afebrile (n=50) | – | Device: Verily PatchAfebrile is defined as having sublingual temperatures of less than 37.5 °C. All subjects will wear the Verily Patch in the axillary region for up to 8 days. In addition, subjects will measure oral and axillary temperatures using a commercially available thermometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 participants (50 febrile and 50 afebrile) will be enrolled at one investigational site. Febrile is defined as having sublingual temperatures of 37.50C or above. Participants that exhibit COVID-19 symptoms and/or COVID-19 diagnosis may be included in the study.
Key inclusion criteria (8 listed)
- At least 18 years old
- Able to read and speak English
- Able to read and understand the Informed Consent Form
- Willing to wear Verily Patch in the axillary region
- Willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding during study participation
- Have known allergies to medical grade adhesives
- Have known cutaneous hypersensitivity
- Have infection in both axilla
- Have open injury or rash where the study device will be worn
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 |
|---|---|---|
| Verily PatchThe Verily Patch is an investigational wearable temperature sensor that consists of a Patch (Verily Patch), with swappable adhesives, as well as an app (Verily Patch app). | Device | Afebrile (n=50), Febrile (n=50) |
Primary outcome
Data collection to support development activities for Verily Patch
Time frame: Up to 8 days
Data collection to enable device development of the Verily Patch, which includes the development of an algorithm that estimates temperature
Results and safety
The study was stopped early (reason given: Decision by the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
William Marks, MD study director
Verily Life Sciences
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 Febrile and Afebrile, run by Verily Life Sciences LLC 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Aug 2021. 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 was stopped early (reason given: Decision by the Sponsor). Results are not available in the source record.
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?
Data collection to support development activities for Verily Patch (time frame: Up to 8 days). 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 2021.