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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT04796935
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 18 years and above, inclusive
2. Subjects scheduled for one of the following procedures:
* Diagnostic LP (collection of CSF and/or measurement of ICP to diagnose hemorrhaging or neurological infections)
* Therapeutic LP (intrathecal injection of therapeutic agents; drainage of CSF to treat pseudotumor cerebri)
* Planned orthopedic or obstetric procedure, such as labor/induction, cesarean section, hysterectomy, or total hip/knee replacement, with neuraxial anesthesia (injection of anesthetic into spinal and/or epidural space to reduce pain during procedure)
* Epidural blood patch (use of autologous blood to close holes in the dura mater and relieve PDPH)
3. Subjects having a BMI ≤42kg/m2
Exclusion Criteria:
1. Patient does not provide informed consent
2. Skin or soft tissue infection near the puncture site
3. Allergy to local anesthetic
4. Uncorrected coagulopathy
5. Acute spinal cord trauma
6. History of lumbar spinal surgery
7. Prior known failed neuraxial anesthesia
8. Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis
9. Incarcerated subjects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04796935
Study Brief:
Protocol Section:
NCT04796935