Clinical trial · Interventional
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation
NCT04796935CI-TRIAL-00077866completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Central Nervous System Infections | — | UNRESOLVED | — |
| Neurological Disorder | — | UNRESOLVED | — |
| Obstetric Procedure Pain | — | UNRESOLVED | — |
| Orthopedic Procedure Pain | — | UNRESOLVED | — |
| Post-Dural Puncture Headache | — | UNRESOLVED | — |
| Pseudotumor Cerebri | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (palpation) | Other | — | UNRESOLVED |
| Tactile Imaging (VerTouch) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group 1: Tactile Imaging (VerTouch)
- description
- VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
- interventionNames
- Device: Tactile Imaging (VerTouch)
- type
- ACTIVE_COMPARATOR
- label
- Group 2: Control (palpation)
- description
- Palpation used to identify and mark an insertion site.
- interventionNames
- Other: Control (palpation)
Primary outcomes (1)
- measure
- Number of Insertion Attempts
- timeFrame
- End of procedure, 1 per participant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.