Status:
COMPLETED
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
Lead Sponsor:
IntuiTap Medical, Inc
Collaborating Sponsors:
ICON plc
Conditions:
Central Nervous System Infections
Pseudotumor Cerebri
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Detailed Description
Neuraxial procedures, in which a needle is inserted into the spinal canal through a gap in the vertebrae, are performed at a rate of nearly 13 million per year in the US, across a myriad of diagnostic...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04796935
Start Date
April 4 2021
End Date
November 24 2021
Last Update
June 11 2024
Active Locations (3)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
University of Texas Health Science Center
Houston, Texas, United States, 77030