Hypertension Clinical Trial
Official title:
Correlation Study of NMT's IQ2, NcIQ and Its' Predicate Technology, IQ101.
The new NcIQ thoracic impedance monitor is based on the predicate device, the IQ101. The new
model uses the same 3-dimensional signal averaging as the original device, but also include
second radio frequency signal to permit the device to work “wirelessly”, i.e., without
electrode lead attachments to the patient. This study seeks to 1) validate the use of the
new device and confirm the correlation of the IQ101 and NcIQ. 2) Evaluate the ease of the
new device.
The new IQ2 thoracic impedance monitor is based on the predicate device, the IQ101. The new
model uses the same 3-dimensional signal averaging as the original device, but with smaller
housing and updated operating software. This study seeks to 1) Validate the use of the new
device and confirm the correlation of the IQ101 and IQ2. 2) Compare the ease of the devices.
The IQ101 is the first generation of the non invasive cardiograph. This device uses
impedance to a micro-electric field passing from the electrodes. The NcIQ uses Radio
frequencies and the same 3 dimensional signal averaging algorithm used in the IQ101 to
generate hemodynamic data. The radio waves enables the device to work without the contact
lead arrays used in the IQ2 and can take measurements without even contacting the patient,
hence can be applied through clothing and is simple to apply. This makes the potential use
by first responders a possibility. The device measures the change in the radio wave
reflection during the cardiac cycle to estimate ardiac function. Specifically, it measures
cardiac output, the amount of blood pumped per minute, and other hemodynamic parameters
previously only measurable with invasive catheters. The data us used to generate a LIFESCORE
and can measure and report dangerous trends to the caretaker. The device has a companion
device to download the data for the hospital providers to create a seamless transfer of
care. The new device uses technology similar to the previous generation machine but has been
miniaturized, given updated operating system, and newer computer technology that helped make
the device smaller, and faster. The underlying patented algorithm was not changed.
Therefore, it is expected to provide the same degree of accuracy and precision as the
predicate device.
The IQ101 is the first generation of the non invasive cardiograph. This device uses
impedance to a micro-electric field passing from the electrodes. The device can use the
impedance and the change in the impedance during the cardiac cycle to estimate thoracic
fluid volumes and cardiac function. Specifically, it measures cardiac output, the amount of
blood pumped per minute, and other hemodynamic parameters previously only measurable with
invasive catheters. There are many studies documenting the device’s performance. The new
device uses the same technology but has been modernized with updated operating system, and
newer computer technology that helped make the device smaller, and faster. The device has
also been redesigned to make operator use simpler and reduce the number wires involved. The
underlying patented algorithm was not changed. Therefore, it is expected to provide the same
degree of accuracy and precision as the predicate device with simplified user interface and
lighter, smaller, more portable housing to improve ease of use.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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