A Clinical Investigation With BARRIER® EasyWarm® | NCT04813809

Studies
A Clinical Investigation With BARRIER® EasyWarm®

NCT04813809

Sponsor

Molnlycke Health Care AB

Status

Completed

Last Update Posted

May 11, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

BARRIER EasyWarm

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2021Actual

Primary Completion Date

Apr 29, 2021Actual

Completion Date

Apr 29, 2021Actual

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2021

Last Update Posted Date

May 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BARRIER EasyWarm	Experimental	This is an open, non randomised, single arm study	Device: BARRIER EasyWarm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BARRIER EasyWarm	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin temperature	Relative change in average skin temperature (ºC)	10 hours

Secondary Outcomes

Measure	Description	Time Frame
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.	30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9 hours
Skin temperature 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided