Cardiox Shunt Detection Technology Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Patent Foramen Ovale
Interventions
DEVICE

Cardiox FDS

The Cardiox Shunt Detection system consists of a sensor placed in contact with the outer ear, similar to a finger probe used to detect oxygen levels in blood. Through an intravenous line, ICG (indocyanine green) at a dosage of 10 mg (2 mL of 5 mg/mL ICG solution) per test, is administered into the right or left antecubital fossa. The presence of ICG in the veins within the outer ear are detected, and the results are displayed on a monitor. All patients will also be evaluated with TCD and TEE for the presence of RTLS.

Trial Locations (7)

10032

Columbia University Medical Center, New York

35249

University of Alabama, Birmingham, Birmingham

43214

Riverside Methodist Hospital, Columbus

85006

Heart and Vascular Center of Arizona, Phoenix

90095

UCLA Medical Center, Los Angeles

98122

Swedish Hospital, Seattle

02111

Tufts Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Cardiox Corporation

INDUSTRY

NCT01333761 - Cardiox Shunt Detection Technology Study | Biotech Hunter | Biotech Hunter