Healthy VolunteersEasyWarm01NCT04813809
A Clinical Investigation With BARRIER® EasyWarm®
A study testing BARRIER EasyWarm in people with Healthy Volunteers, run by Molnlycke Health Care AB at 1 site in Sweden.
Trial summary
This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BARRIER EasyWarm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 14 Apr 2021to 29 Apr 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Adult males and females ≥ 18 years old
- Able to maintain a supine position up to 10 hours.
Who cannot join
- Diseases/medical treatments that affect normal body temperature control:
- Persons who have/have had thyroid disease or who are treated with medications affecting the thyroid hormones
- Persons being treated with medication affecting normal body temperature control, based on investigator judgement.
- Impaired circulation/vascular disease
- Impaired sensitivity/neuropathy
- Active skin disease
Show all 9Show fewer
- Female with temperature variations due to menopause
- Pregnancy or lactation at time of study participation.
- Person not suitable for the investigation according to the clinician's judgement.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
/Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum
Gothenburg, 41345
About this study
Official title: A Prospective, Open, Non-comparative, Single-centre Investigation to Study the Effect of BARRIER® EasyWarm® Active Self-warming Blanket on Skin- and Body Core Temperatures in Healthy Volunteers
This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site and each subject will be evaluated for up to 10 hours in one visit.
Read the detailed description
This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures.
The investigation will enroll approximately 20 healthy volunteers in one investigation site. Each subject will be evaluated for up to 10 hours in one visit on site. Body core- and skin reference temperatures will be established before applying the blanket. After reference temperature assessments, the BARRIER EasyWarm is positioned on the subject with the neckline at the collarbone. Skin temperatures will be assessed with an IR camera and body core temperatures will be assessed with an ear thermometer at 30 min, 1 hour, 2, 3, 4, 5, 6, 7, 8, 9, and 10 hours post blanket application. Subject perception of heat from the blanket will be assessed at 30 minutes, 5 hours and 10 hours post blanket application by means of a five graded question.
- Conditions
- Healthy Volunteers
- Being tested
- BARRIER EasyWarm
- Keywords
- Body temperature, Healthy volunteers, EasyWarm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BARRIER EasyWarmDevice
Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.
| Study group | Role | What they receive |
|---|---|---|
| BARRIER EasyWarm | Experimental | This is an open, non randomised, single arm study Receives: Device: BARRIER EasyWarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
Relative change in average skin temperature (ºC)
Measured: 10 hours
Secondary outcomes (6)
Skin temperature 1
Relative change in average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8 and 9 hours (ºC). Assessed with an IR camera.
Measured: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours
Skin temperature 2
Maximum skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera.
Measured: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours
Skin temperature 3
Average skin temperature at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours (ºC). Assessed with an IR camera.
Measured: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core Temperature 1
Body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours. Assessed with an ear thermometer.
Measured: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core temperature 2
Relative change in body core temperature (ºC) at 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours compared to baseline. Assessed with an ear thermometer.
Measured: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Heat perception
Five-point question related to perception of heat from the BARRIER EasyWarm. Assessed at 30 minutes, 5 hours and 10 hours post application. Scale: Cold, cool, not cool or warm, warm, hot.
Measured: 30 minutes, 5 hours and 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start14 Apr 2021
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813809
- Sponsor's protocol ID
- EasyWarm01
- Acronym
- EasyWarm01
- Status last verified
- May 2021
- First submitted
- 22 Mar 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-comparative, Single-centre Investigation to Study the Effect of BARRIER® EasyWarm® Active Self-warming Blanket on Skin- and Body Core Temperatures in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04813809
- Acronym / sponsor ID
- EasyWarm01 / EasyWarm01
- Conditions
- Healthy Volunteers
- Keywords
- Body temperature, Healthy volunteers, EasyWarm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 24 Mar 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 investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures. The investigation will enroll approximately 20 healthy volunteers in one investigation site and each subject will be evaluated for up to 10 hours in one visit.
Detailed description
This investigation is a prospective, open, non-comparative, single-center investigation with the aim to investigate the effect of BARRIER EasyWarm active self-warming blanket on skin- and body core temperatures.
The investigation will enroll approximately 20 healthy volunteers in one investigation site. Each subject will be evaluated for up to 10 hours in one visit on site. Body core- and skin reference temperatures will be established before applying the blanket. After reference temperature assessments, the BARRIER EasyWarm is positioned on the subject with the neckline at the collarbone. Skin temperatures will be assessed with an IR camera and body core temperatures will be assessed with an ear thermometer at 30 min, 1 hour, 2, 3, 4, 5, 6, 7, 8, 9, and 10 hours post blanket application. Subject perception of heat from the blanket will be assessed at 30 minutes, 5 hours and 10 hours post blanket application by means of a five graded question.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BARRIER EasyWarm | Experimental | Device: BARRIER EasyWarmThis is an open, non randomised, single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- Adult males and females ≥ 18 years old
- Able to maintain a supine position up to 10 hours.
Key exclusion criteria (9 listed)
- Diseases/medical treatments that affect normal body temperature control:
- Impaired circulation/vascular disease
- Impaired sensitivity/neuropathy
- Active skin disease
- Female with temperature variations due to menopause
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 |
|---|---|---|
| BARRIER EasyWarmApplication of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device. | Device | BARRIER EasyWarm |
Primary outcome
Skin temperature
Time frame: 10 hours
Relative change in average skin temperature (ºC)
6 secondary outcomes
Skin temperature 1
Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours
Skin temperature 2
Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours
Skin temperature 3
Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core Temperature 1
Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core temperature 2
Time frame: 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Heat perception
Time frame: 30 minutes, 5 hours and 10 hours
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 11 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BARRIER EasyWarm in people with Healthy Volunteers, run by Molnlycke Health Care AB at 1 site in Sweden.
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 9 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 May 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 Sweden. 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?
Skin temperature (time frame: 10 hours). 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 May 2021.