NCT00598819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2010

Completed
Last Updated

August 17, 2011

Status Verified

August 1, 2011

Enrollment Period

1.6 years

First QC Date

December 19, 2007

Results QC Date

January 15, 2010

Last Update Submit

August 15, 2011

Conditions

Cerebral Ischemia

Keywords

Cerebral OxygenationOxygen Monitoring

Outcome Measures

Primary Outcomes (3)

  • Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.

    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. Measurement and reactions assessment performed by the investigator.

    attachment of sensor to 24 hours post-removal

  • Overheating of Skin Underneath Sensor.

    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; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.

    placement of sensor to 10 minutes post-removal.

  • Overheating of Skin Underneath Sensor

    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; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.

    placement of sensor to immediately post-removal

Secondary Outcomes (2)

  • Sensor Fits Well on Subjects Forehead

    placement of sensor to end of study observation

  • Sensor Attachment Under Stress

    addition of stress on sensor to removal.

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Healthy subjects testing the device.

Device: CDI 1000 COM

Interventions

CDI 1000 COMDEVICE

CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.

Also known as: Terumo CDI 1000 COM
Healthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or Female Volunteers
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

No Adverse Events (AE's) or Serious Adverse Events (SAE's) were reported in this study.

Results Point of Contact

Title
Dr. Jeffrey C. Milliken
Organization
University of California, Irvine Medical Center
jcmillik@uci.edu
714-456-3634

Study Officials

  • Jeffrey C Milliken, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2007

First Posted

January 23, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 17, 2011

Results First Posted

July 7, 2010

Record last verified: 2011-08

Locations

US(1)