SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

  • STATUS
    Not Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    250
  • sponsor
    SGX Nova LLC
Updated on 13 June 2022
back pain
spinal cord
low back pain
leg pain
intractable pain

Summary

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.

Description

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

  • Test treatment group with DTM-SCS programming approach
  • Control treatment group with Conventional SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.

Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.

This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.

The expected total duration of this study is approximately 32 months.

Details
Condition backache, Pain, Post-Surgical Pain, backpain, Chronic Back Pain, Pain (Pediatric), Back Pain
Treatment DTM Programming, Conventional SCS programming
Clinical Study IdentifierNCT04571242
SponsorSGX Nova LLC
Last Modified on13 June 2022

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note