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:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT05373667
Eligibility Criteria:
Inclusion Criteria:
* 1\. Have a clinical diagnosis of chronic predominant pelvic pain as determined by a multidisciplinary study team.
2\. Score 13 or greater in PainDETECT questionnaire 3. 4. Have been refractory to conservative therapy for a minimum of 3 months, including assessment of at least 2 different classes of medications.
5\. Average pain intensity (over the last 7 days) of ≥ 5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (in accordance with the NICE guidelines).
6\. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
7\. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion.
8\. Be 18 years of age or older at the time of enrollment. 9. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
10\. Be capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written inform consent.
11\. Be willing and capable of giving informed consent. 12. Be willing and able to comply with study-related requirements, procedures, and visits.
13\. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
Exclusion Criteria:
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia).
2. Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury as determined by the investigator.
3. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator.
4. Significant stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by MRI conducted within the past 12 months.
5. Have a clinical diagnosis of unstable mental health condition or severe depression \[request input on this exclusion criteria from the psychologist\] including suicidal ideation.
6. Be benefitting within from an interventional procedure and/or surgery to treat chronic pelvic pain (Subjects should be enrolled at least 30 days from last benefit).
7. Have an existing drug pump and/or another active implantable device such as a pacemaker.
8. Have failed other neuromodulation therapies including traditional SCS, peripheral nerve stimulation or dorsal root ganglion stimulation.
9. Have metastatic malignant disease or active local malignant disease.
10. Have a life expectancy of less than 1 year.
11. Have an active systemic or local infection at the anticipated needle entry site.
12. Be pregnant or plan to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
13. Are currently nursing (if female).
14. Have been immunocompromised.
15. Have been known to be allergic or have shown hypersensitivity to any materials of the neurostimulation system which come in contact with the body.
16. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including opioids, benzodiazepines, alcohol and illicit drugs).
17. Be concomitantly participating in another clinical study.
18. Be involved in an injury claim under current litigation.
19. Have a pending or approved worker's compensation claim.
20. Presence of pelvic tumor including benign.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05373667
Study Brief:
Protocol Section:
NCT05373667