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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06407167
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-85 years;
2. Radicular leg pain with or without neurogenic claudication with or without back pain;
3. Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
4. Symptoms persisting for at least 3 months prior to surgery;
5. Given written Informed Consent;
6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
Exclusion Criteria:
1. Prior lumbar fusion at any level;
2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
3. Back or non-radicular pain of unknown etiology;
4. History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06407167
Study Brief:
Protocol Section:
NCT06407167