Phase 1 N=14 Diagnostic

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

Cerebral Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT00598819 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. — 0; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CDI 1000 COM (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.	0; 14	—
PRIMARY Overheating of Skin Underneath Sensor.	0; 14	—
PRIMARY Overheating of Skin Underneath Sensor	0; 14	—
SECONDARY Sensor Fits Well on Subjects Forehead	14; 0	—
SECONDARY Sensor Attachment Under Stress	0; 14	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00598819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.