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Cardiox Shunt Detection Technology Study

This study has been terminated.
(1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.)
Sponsor:
Information provided by (Responsible Party):
Cardiox Corporation
ClinicalTrials.gov Identifier:
NCT01333761
First received: March 31, 2011
Last updated: January 8, 2013
Last verified: January 2013

March 31, 2011
January 8, 2013
April 2011
July 2012   (final data collection date for primary outcome measure)
  • To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01333761 on ClinicalTrials.gov Archive Site
To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt [ Time Frame: 1 day ] [ Designated as safety issue: No ]
To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt [ Time Frame: At time of FDS and TCD testing (same day as TEE testing) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiox Shunt Detection Technology Study
FDS-0004 Cardiox Shunt Detection Technology Study

The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Patent Foramen Ovale
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.
Experimental: TCD/Cardiox FDS/TEE testing
All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.
Intervention: Device: Cardiox FDS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
71
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eighteen (18) years of age or older
  • Informed consent documentation understood and signed
  • Planned or completed TEE study within the last 12 months

Exclusion Criteria:

  • Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to Iodide Contrast Dye or Iodides
  • Pregnant women or nursing mothers
  • Subject unable or unwilling to understand and sign the informed consent
  • Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of post screening
  • Subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine > 2.0 or subjects currently being followed by a nephrologist
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333761
FDS-0004
No
Cardiox Corporation
Cardiox Corporation
Not Provided
Not Provided
Cardiox Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP