Thermometry Device ComparisonsNCT01255865
Comparison Study of Core Temperature Thermometry Systems
An observational study of Thermometry Device Comparisons, run by 3M at 1 site in United States.
Trial summary
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thermometry Device Comparisons
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 120 subjects of any racial, gender, or ethnic background in who simultaneous measurments of deep tissue, oral, or rectal temperature can be made
Who may be able to join
- -
Who cannot join
- Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Tissue Thermometry 510(k) Premarket Notification Trial
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
Read the detailed description
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- Conditions
- Thermometry Device Comparisons
- Keywords
- Thermometry, Deep Tissue Temperature, Core Temperature, Body Temperature, Rectal Temperature, Oral Temperature
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 |
|---|---|---|
| A1 - up to 1 month | Age group 0 up to 1 month | |
| A2 - 1 to 3 months | Age group from 1 month to 3 months | |
| A3 - 3 months to 1 year | Age group from 3 months to 1 year | |
| B - 1 year to 5 years | Age group from older than 1y and younger than 5 years | |
| C - 5 years to 12 years | Age group from older than 5y and younger than 12 years | |
| D - 12 years to 21 years | Age group from older than 12 years and younger than 21 years | |
| E - 21 years and older | Age group older than 21 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature Agreement in Degrees Celsius.
Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionDec 2011
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 Thermometry Device ComparisonsStudies 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
- Case crossover
- Time perspective
- Other
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel i Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255865
- Sponsor's protocol ID
- Arizant 10-1026
- Status last verified
- Aug 2020
- First submitted
- 6 Dec 2010
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Tissue Thermometry 510(k) Premarket Notification Trial
- ClinicalTrials.gov ID
- NCT01255865
- Acronym / sponsor ID
- Arizant 10-1026
- Conditions
- Thermometry Device Comparisons
- Keywords
- Thermometry, Deep Tissue Temperature, Core Temperature, Body Temperature, Rectal Temperature, Oral Temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 25 Aug 2020
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 trial is the generation of clinical data required for a 510(k) submission to the FDA.
Detailed description
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A1 - up to 1 month | – | –Age group 0 up to 1 month |
| A2 - 1 to 3 months | – | –Age group from 1 month to 3 months |
| A3 - 3 months to 1 year | – | –Age group from 3 months to 1 year |
| B - 1 year to 5 years | – | –Age group from older than 1y and younger than 5 years |
| C - 5 years to 12 years | – | –Age group from older than 5y and younger than 12 years |
| D - 12 years to 21 years | – | –Age group from older than 12 years and younger than 21 years |
| E - 21 years and older | – | –Age group older than 21 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 120 subjects of any racial, gender, or ethnic background in who simultaneous measurments of deep tissue, oral, or rectal temperature can be made
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
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
Temperature Agreement in Degrees Celsius.
Time frame: Upon enrollment
Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Outcomes Research ConsortiumLink provided by the sponsor.
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.
Daniel i Sessler, MD principal investigator
The Cleveland Clinic
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 Thermometry Device Comparisons, run by 3M 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 1 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 25 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2020). 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?
Temperature Agreement in Degrees Celsius. (time frame: Upon enrollment). 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 25 Aug 2020.