Correlation Research Study: IQ2, NcIQ and IQ101

Hypertension Clinical Trial

— NMT-CT  

Official title:

Correlation Study of NMT's IQ2, NcIQ and Its' Predicate Technology, IQ101.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491777
• Other study ID #: NMT-IQ2/NcIQ
• Status: Completed
• Phase: Phase 1
• First received: June 22, 2007
• Last updated: June 22, 2007
• Start date: June 2007
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: Noninvasive Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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”, 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria:

• Age – 18-80 years

• Weight – 80-300 pounds

• Height – 5.0 feet – 6feet 4 inches Exclusion Criteria

• Ongoing medical emergency or acute medical illness

• NcIQ or ECG electrode adhesive allergy or sensitivity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure
• Hypertension
• Pacemaker
• Trauma

Intervention

Device:
• Noninvasive Hemodynamic Patient Monitor

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Noninvasive Medical Technologies, Inc.	Shand's Medical Center, University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A direct correlation between output parameters of IQ2/NcIQ to IQ101