Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491777
Status:
COMPLETED
Last Update Posted:
2007-06-26
First Post:
2007-06-22
Brief Title:
Correlation Research Study IQ2 NcIQ and IQ101
Sponsor:
Noninvasive Medical Technologies Inc
Organization:
Noninvasive Medical Technologies Inc
Study Overview
Official Title:
Correlation Study of NMTs IQ2 NcIQ and Its Predicate Technology IQ101
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NMT-CT
Brief Summary:
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 ie 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 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
Detailed Description:
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 devices 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
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 devices 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None