A Clinical Investigation With BARRIER® EasyWarm®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2021-04-29

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BARRIER EasyWarm

This is an open, non randomised, single arm study

Group Type EXPERIMENTAL

BARRIER EasyWarm

Intervention Type DEVICE

Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.

Interventions

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BARRIER EasyWarm

Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed consent
2. Adult males and females ≥ 18 years old
3. Able to maintain a supine position up to 10 hours.

Exclusion Criteria

1. 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.
2. Impaired circulation/vascular disease
3. Impaired sensitivity/neuropathy
4. Active skin disease
5. Female with temperature variations due to menopause
6. Pregnancy or lactation at time of study participation.
7. Person not suitable for the investigation according to the clinician's judgement.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes