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A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control

NCT04796935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-06-11

Study results available
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Summary

This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

Conditions

  • Central Nervous System Infections
  • Pseudotumor Cerebri
  • Neurological Disorder
  • Cancer
  • Obstetric Procedure Pain
  • Orthopedic Procedure Pain
  • Post-Dural Puncture Headache

Interventions

DEVICE

Tactile Imaging (VerTouch)

VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.

OTHER

Control (palpation)

Control, palpation used to identify and mark an insertion site.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • IntuiTap Medical, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-04
Primary Completion
2021-11-24
Completion
2021-11-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796935 on ClinicalTrials.gov