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NCT02226614 Clinical Trial

Development of a Head Cooling Device

Body Temperature Changes Clinical Trial

Official title:
Development of a Head-cooling Device for Brain Injury: Healthy Volunteer Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02226614
Other study ID # vs1 25.03.14
Secondary ID
Status Completed
Phase N/A
First received July 22, 2014
Last updated June 14, 2016
Start date August 2014
Est. completion date February 2016

Study information
Verified date December 2015
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority Scotland: Scottish Executive Health Department
Study type Interventional

Clinical Trial Summary

This study is testing a head-cooling device on volunteers to assess temperature reduction.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- healthy humans

Exclusion Criteria:

- pregnant

- refusal of consent for registration with The Over-volunteering Protection Scheme

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• University of Edinburgh head cooling device
head cooling

Locations
Country Name City State
United Kingdom Western General Hospital Edinburgh

Sponsors (1)
Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature change 6 hours No
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