N/A
N=90
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
Central Nervous System Infections · Pseudotumor Cerebri · Neurological Disorder · Cancer · Obstetric Procedure Pain
Bottom Line
View on ClinicalTrials.gov: NCT04796935 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Insertion Attempts — 1.8; 2.2; 1.2; 2.1 insertions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tactile Imaging (VerTouch) (Device); Control (palpation) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IntuiTap Medical, Inc
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Insertion Attempts |
1.8; 2.2; 1.2; 2.1 | — |
| SECONDARY Incidence of First-insertion Success |
25; 25; 21; 25 | — |
| SECONDARY Number of Redirections |
4.5; 5.8; 2.5; 5.2 | — |
| SECONDARY Number of Passes |
6.4; 8.0; 3.8; 7.3 | — |
| SECONDARY Incidence of First-pass Success |
10; 9; 9; 9 | — |
| SECONDARY Subject Discomfort During Landmarking |
2.0; 1.9; 1.5; 1.5 | — |
| SECONDARY Provider Confidence With the Identified Insertion Site |
3.6; 4.2; 4.0; 4.2 | — |
Summary
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04796935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.