top of page

The Nu-V3 Clinical Program

Screen Shot 2021-01-15 at 10.05.55 AM.pn

The Treatment Protocol

The following describes each step of the Nu-V3 Clinical Programs.  The actual treatment protocol, which will be utilized for our initiatives, pre market, may differ slightly from program to program depending on logistical differences from clinic to clinic.  These protocols are designed to be nearly identical to the protocols that drive the Nu-V3 Clinical Programs, once we enter the marketplace in 2021.  Below, we clearly describe each step in the program process to demonstrate the simplicity and ease of use for the provider as well as the patient.  Each step is accompanied by links to more detailed information.  In addition, we provide a Clinical Process document to describe the steps of the clinical programs and initiatives to ensure consistency and understanding of the process itself.

Screen Shot 2020-06-11 at 1.03.15 PM.png
The Initial Consultation - In person or remotely

Prospective patients for the Nu-V3 clinical program may come from within the clinical environment or may be recruited from outside the clinic.  This may depend largely upon the patient base and number of viable patients available.  The initial consultation is designed to determine at an entry level, whether the Nu-V3 program is a good choice for them and the likelihood that the patient may receive significant benefit.  High level exclusion criteria such as patients who are under 18, pregnant or have a pacemaker may be utilized at this stage to streamline the flow of patient intake interviews.

iStock-1029340652.jpg
The Intake Interview - In person

Once the patient has been selected and approved for the clinical program, the intake interview is completed to finalize approval for the patient's participation and execute documentation such as Informed Consent and authorizations for use of results and data.   This is also the time for the patient to ask any final questions and for the provider to set the expectations for participation.  Once completed, the patient is scheduled for the initial on-boarding, device placement and HRV test.

Post market copy.png
Patient Education and Setting Expectations - In person or remotely

A number of tools are provided for patient education covering both the placement and use of Nu-V3 and also the HRV test.  In addition to the introductory video they have seen during the Intake Interview, we provide a video taking the patient through an actual treatment along with a tutorial on treatment program.  Web based and live line resources are also provided for patient support. Once the patient understands the safety, simplicity of the device placement and HRV test and the ease of use, any anxiety regarding the treatment is significantly reduced.

iStock-1134710901.jpg
Prepare for Initial Treatment - In person

Preparing the patient, device and PADS assembly is very straightforward and should take no more than 5 - 10 minutes.  The specific steps for preparing the patient,PADS, the device and the HRV test are included in the Instructions for Use.  A hard copy version comes with the Nu-V3 kit and an animated version is also provided on line.  We suggest preparing the device and HRV testing equipment in advance and once the patient is in the treatment room, have them relax for a few moments before administering the HRV test.  This test is simple and takes just 30 seconds but a relaxed patient results in a more accurate baseline test.

Screen Shot 2020-03-29 at 3.05.00 PM.png
Initial Heart Rate Variability Test - In person

The HRV test or Heart Rate Variability test begins with a simple ECG done by the patient placing their fingers on the HRV pad for 30 seconds.  Thats it.  The ECG is then delivered to our software wirelessly, which evaluates the ECG data and tells among other things, us how the patient autonomic nervous system is performing and where the balance is between the sympathetic and parasympathetic systems are.  

Screen Shot 2021-01-14 at 12.00.22 PM.pn
Nu-V3 Device Application - In person or remotely

The Nu-Life design and production team has recently accelerated our efforts for the Remote Treatment Program and in doing so has:

  • Created a Nu-V3 device which is simple for the patient to apply themselves

  • Developed easy-to-follow instructions as well as video tutorials and a live hotline

  • Engineered the device so that only one per month is needed.

  • Created a 24/7 virtual support system for any questions the patient may have

Screen Shot 2020-06-11 at 1.06.46 PM.png
24 Hour Follow-up - Remotely

Comprehensive support and aftercare once the program has been completed is very important.  Each patient receives an HRV (Heart Rate Variability) wearable device at the beginning of the program, which will also be used in aftercare to collect precise HRV data critical to tracking the patient's progress and also alerting the Nu-Life team if the patient's symptoms begin to return, long after the program has been completed.

Screen Shot 2020-06-11 at 1.05.55 PM.png
Weekly Check-in and PADS Replacement - In person or remotely

During the Nu-V3 Remote Treatment Program, the patient is advised to refrain from strenuous tasks or activities which they have not performed in some time, due to their illness, adverse event or recovery. Once the program is complete and both patient and clinical staff agree that the patient is able to enter the aftercare phase of the program, we want to hear from our patients about their new lives!  If they need us in the future, we will be there.

Calendar Icon.png
Device Replacement - Once Every 4 Weeks - In person or remotely

During the Nu-V3 Remote Treatment Program, the patient is advised to refrain from strenuous tasks or activities which they have not performed in some time, due to their illness, adverse event or recovery. Once the program is complete and both patient and clinical staff agree that the patient is able to enter the aftercare phase of the program, we want to hear from our patients about their new lives!  If they need us in the future, we will be there.

iStock-1134710915.jpg
12 Week Treatment Program Conclusion and Assessment - In person

During the Nu-V3 Remote Treatment Program, the patient is advised to refrain from strenuous tasks or activities which they have not performed in some time, due to their illness, adverse event or recovery. Once the program is complete and both patient and clinical staff agree that the patient is able to enter the aftercare phase of the program, we want to hear from our patients about their new lives!  If they need us in the future, we will be there.

iStock-1224749397.jpg
12 Week Maintenance Program - In person and remotely

During the Nu-V3 Remote Treatment Program, the patient is advised to refrain from strenuous tasks or activities which they have not performed in some time, due to their illness, adverse event or recovery. Once the program is complete and both patient and clinical staff agree that the patient is able to enter the aftercare phase of the program, we want to hear from our patients about their new lives!  If they need us in the future, we will be there.

Screen Shot 2020-06-11 at 2.58.02 PM.png
12 Month Aftercare - Remotely

During the Nu-V3 Remote Treatment Program, the patient is advised to refrain from strenuous tasks or activities which they have not performed in some time, due to their illness, adverse event or recovery. Once the program is complete and both patient and clinical staff agree that the patient is able to enter the aftercare phase of the program, we want to hear from our patients about their new lives!  If they need us in the future, we will be there.

bottom of page