Study of a New Clinical Device for Reducing Body Core Temperature
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|ClinicalTrials.gov Identifier: NCT01996982|
Recruitment Status : Terminated (The Prinicipal Investigator left the organization and decided to close the trial)
First Posted : November 27, 2013
Last Update Posted : April 27, 2017
This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human subjects will provide data that will be used to improve a specialized human heat transfer technique/device. By stimulating specialized blood vessels (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase local blood flow and thus greatly increase the potential for effective heat transfer between the environment and body.
The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a practical, safe, and effective method to raise or lower body temperature in critically ill patients.
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Device: CCS Device||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of a New Clinical Device for Reducing Body Core Temperature|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
CCS Device application
Device: CCS Device
Core Cooling System Device
- Adverse events from application and use of the Core Cooling System (CCS) device. [ Time Frame: 1 year after the enrollment is closed ]
- Assess and capture all adverse events (if any) from application and use of the CCS device.
- Also assess CCS device interference with participant's standard of care.
- Number of participant's with adverse events from induction of therapeutic hypothermia (TH). [ Time Frame: 1 year after the enrollment is closed. ]Assess and capture all adverse events from induction of TH with CCS device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996982
|United States, Texas|
|University Medical Center Brackenridge|
|Austin, Texas, United States, 78701|
|Seton Medical Center|
|Austin, Texas, United States, 78705|
|Principal Investigator:||Alex B Valadka, MD, FACS||Seton Healthcare Family|