Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Orange, California 92868


Purpose:

The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.


Study summary:

Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.


Criteria:

INCLUSION CRITERIA: - Healthy male or Female Volunteers - 18 years old or older - Capable and willing to operate a bicycle - Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study EXLUSION CRITERIA: - History of Cerebrovascular Disease - History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.) - Pregnancy


Study is Available At:


Original ID:

2007-5593


NCT ID:

NCT00598819


Secondary ID:


Study Acronym:


Brief Title:

A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers


Official Title:

A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey C Milliken, MD
Principal Investigator
University of California, Irvine

Study Dates

Start Date:October 2007
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:August 2011
Last Changed Date:August 15, 2011
First Received Date:December 19, 2007
First Results Date:January 15, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
Time Frame:attachment of sensor to 24 hours post-removal
Safety Issues:True
Description:Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measu
Outcome Type:Primary Outcome
Measure:Overheating of Skin Underneath Sensor.
Time Frame:placement of sensor to 10 minutes post-removal.
Safety Issues:True
Description:The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; I
Outcome Type:Primary Outcome
Measure:Overheating of Skin Underneath Sensor
Time Frame:placement of sensor to immediately post-removal
Safety Issues:True
Description:The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; I
Outcome Type:Secondary Outcome
Measure:Sensor Fits Well on Subjects Forehead
Time Frame:placement of sensor to end of study observation
Safety Issues:False
Description:How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test
Outcome Type:Secondary Outcome
Measure:Sensor Attachment Under Stress
Time Frame:addition of stress on sensor to removal.
Safety Issues:False
Description:The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; I

Study Interventions

Intervention Type:Device
Name:CDI 1000 COM
Description:CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
Arm Name:Healthy Volunteers
Other Name:Terumo CDI 1000 COM

Study Arms

Study Arm Type:Experimental
Arm Name:Healthy Volunteers
Description:Healthy subjects testing the device.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.