Viewing Study NCT01029314



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Last Modification Date: 2024-10-26 @ 10:13 AM
Study NCT ID: NCT01029314
Status: COMPLETED
Last Update Posted: 2009-12-09
First Post: 2009-12-07

Brief Title: Pilot Study of the GeniusTM2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Sponsor: Tyco Healthcare Group
Organization: Tyco Healthcare Group

Study Overview

Official Title: Pilot Study of the GeniusTM2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Status: COMPLETED
Status Verified Date: 2009-12
Last Known Status: None
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: None
Brief Summary: Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000TM temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass Study hypothesis The Genius 2 thermometer will display greater precision and accuracy than the Exergen TAT-5000 thermometer when compared to core body temperature in patients undergoing CABG surgery
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None