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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT04580732
Eligibility Criteria:
Inclusion Criteria:
A. Capable of giving informed consent and willing to follow all study related procedures;
B. Women and men \>18 years of age;
C. Baseline VAS score of \> 5;
D. History of chronic, function-limiting knee pain of at least three months;
E. Not had recent surgical procedures of the knee within the last three months;
F. ≥50% temporary relief from temporary nerve diagnostics;
G. No evidence of anatomic abnormalities that could jeopardize the placement of the device;
H. Able to operate programmer, recharger, study assessments and provide accurate responses;
I. Appropriate candidate for the implant procedure based on the opinion of investigator.
Exclusion Criteria:
A. An active implantable electronic device regardless of whether stimulation is ON or OFF;
B. Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
C. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study;
D. Subject noted no relief from temporary nerve diagnostics;
E. Inability to achieve appropriate positioning;
F. Inability to understand informed consent and protocol;
G. Conditions requiring recurring MRI evaluation or diathermy procedures;
H. Anatomical restrictions such that device placement is not possible;
I. Have a life expectancy of less than 1-year;
J. Worker's compensation claimants;
K. Based on opinion of investigator any legal concerns that would preclude his/her enrollment in the study or potentially confound results;
L. Deemed unsuitable for enrollment by investigator based on medical history or physical examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04580732
Study Brief:
Protocol Section:
NCT04580732