AzTrials
AzTrials

Heart FailurePhase 1NMT-CTNCT00491777

Correlation Research Study: IQ2, NcIQ and IQ101

A Phase 1 study testing Noninvasive Hemodynamic Patient Monitor in people with Heart Failure and Dyspnea, run by Noninvasive Medical Technologies, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Heart Failure, Dyspnea, Hypertension
What is being tested?
Noninvasive Hemodynamic Patient Monitor
Type of treatment
Medical device
How many people
25 participants
Where
No sites listed yet
Study dates
Jun 2007to Jun 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

About this study

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.

Read the 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 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.

Being tested
Noninvasive Hemodynamic Patient Monitor
Keywords
Noninvasive, Hemodynamic, Monitoring, Critical Care, Swan-Ganz
Medical subject headings
Heart Failure, Dyspnea, Hypertension, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noninvasive Hemodynamic Patient MonitorDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A direct correlation between output parameters of IQ2/NcIQ to IQ101

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00491777
Sponsor's protocol ID
NMT-IQ2/NcIQ
Acronym
NMT-CT
Status last verified
Jun 2007
First submitted
22 Jun 2007
Last updated
26 Jun 2007
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Noninvasive Hemodynamic Patient Monitor in people with Heart Failure and Dyspnea, run by Noninvasive Medical Technologies, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A direct correlation between output parameters of IQ2/NcIQ to IQ101. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2007.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Correlation Research Study: IQ2, NcIQ and IQ101 | AzTrials