Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT04709757
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 90
* 1-year or more use of continuous HF10 therapy as delivered a permanently implanted Nevro Omnia Neurostimulation System for chronic back and/or leg pain
* Some level of decreasing pain relief from their SCS system (see fig. 3)
* Willing and able to complete protocol requirements, including:
* Complete health questionnaires and pain scales as specified in the protocol
* Sign the study-specific informed consent form
* Complete follow-ups at the designated time periods
Exclusion Criteria:
* Previous intermittent dosing usage and/or failure
* Cervical SCS system
* Other concurrent neuromodulation system in place
* Current daily morphine milligram equivalent usage 90mg or higher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04709757
Study Brief:
Protocol Section:
NCT04709757