A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
Completed · Not applicable
Conditions studied: Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain, Post-Dural Puncture Headache
In brief
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Key facts
- Study ID
- NCT04796935
- Run by
- IntuiTap Medical, Inc
- People needed
- 95
- Starts
- 2021-04-04
- Expected to finish
- 2021-11-24
- Last updated by the study team
- 2024-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females aged 18 years and above, inclusive
- 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)
- Subjects having a BMI ≤42kg/m2
You may not qualify if…
- Patient does not provide informed consent
- Skin or soft tissue infection near the puncture site
- Allergy to local anesthetic
- Uncorrected coagulopathy
- Acute spinal cord trauma
- History of lumbar spinal surgery
- Prior known failed neuraxial anesthesia
- Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis
- Incarcerated subjects
Where it is running
- Rhode Island Hospital — Providence, Rhode Island, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Texas Health Science Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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