Clinical Trial: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers
Brief Summary: The primary objective of the study is to validate that the production equivalent PM7100 System in conjunction with Adult Sensors (PMSENS71-A) meet product requirements for cerebral accuracy, cerebral trending accuracy, and somatic trending.
Detailed Summary:
Sponsor: Medtronic - MITG
Current Primary Outcome: Validate that the production equivalent PM7100 System in conjunction with Adult Sensors (PMSENS71-A) [ Time Frame: Data collected from individual participant over 4 hour timeframe. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic - MITG
Dates:
Date Received: April 5, 2017
Date Started: May 15, 2017
Date Completion: July 14, 2017
Last Updated: April 20, 2017
Last Verified: April 2017