Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 4:48 PM
Study NCT ID:
NCT02691832
Status:
UNKNOWN
Last Update Posted:
2016-02-25
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Core Body Temperature Using a Novel Non-invasive Sensor
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dräger
Brief Summary:
The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.
Detailed Description:
12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: