A Clinical Investigation With BARRIER® EasyWarm®
EasyWarm01
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
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Apr 2021
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
April 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2021
CompletedMay 11, 2021
May 1, 2021
15 days
March 22, 2021
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Skin temperature
Relative change in average skin temperature (ºC)
10 hours
Secondary Outcomes (6)
Skin temperature 1
30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours
Skin temperature 2
30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 hours
Skin temperature 3
30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core Temperature 1
30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
Body Core temperature 2
30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 hours
- +1 more secondary outcomes
Study Arms (1)
BARRIER EasyWarm
EXPERIMENTALThis is an open, non randomised, single arm study
Interventions
Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.
Eligibility Criteria
You may qualify if:
- Provision of informed consent
- Adult males and females ≥ 18 years old
- Able to maintain a supine position up to 10 hours.
You may not qualify if:
- Diseases/medical treatments that affect normal body temperature control:
- I. Persons who have/have had thyroid disease or who are treated with medications affecting the thyroid hormones
- II. Persons being treated with medication affecting normal body temperature control, based on investigator judgement.
- Impaired circulation/vascular disease
- Impaired sensitivity/neuropathy
- Active skin disease
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
/Sahlgrenska University Hospital/Clinical Trial Center/Gothia Forum
Gothenburg, 41345, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
April 14, 2021
Primary Completion
April 29, 2021
Study Completion
April 29, 2021
Last Updated
May 11, 2021
Record last verified: 2021-05