Central Nervous System InfectionsNCT04796935
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
A study testing Tactile Imaging (VerTouch) in people with Central Nervous System Infections and Pseudotumor Cerebri, run by IntuiTap Medical, Inc at 3 sites in United States.
Trial summary
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder
- What is being tested?
- Tactile Imaging (VerTouch)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2021to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prior known failed neuraxial anesthesia
- Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis
- Incarcerated subjects
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Health Science Center
Houston, Texas, 77030
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: 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
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Read the 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 and therapeutic clinical scenarios.
The standard of care involves manual palpation of the patient's back to detect the spinous processes (SPs) and estimate the location of the interspinous needle insertion site. While providers are trained to perform these procedures with meticulous precision and attention to detail, this technique remains highly inaccurate, often requiring multiple insertion attempts to properly place the needle. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput.
The VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site.
Study participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain
- Being tested
- Tactile Imaging (VerTouch), Control (palpation)
- Keywords
- Diagnostic spinal puncture, Therapeutic spinal puncture, Lumbar puncture, Epidural, Neuraxial anesthesia, Blood patch, ESI
- Medical subject headings
- Central Nervous System Infections, Pseudotumor Cerebri, Nervous System Diseases, Neoplasms, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile Imaging (VerTouch)Device
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.
Control (palpation)Other
Control, palpation used to identify and mark an insertion site.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Experimental | VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. Receives: Device: Tactile Imaging (VerTouch) |
| Group 2: Control (palpation) | Active comparator | Palpation used to identify and mark an insertion site. Receives: Other: Control (palpation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Insertion Attempts
Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.
Measured: End of procedure, 1 per participant
Secondary outcomes (6)
Incidence of First-insertion Success
A case that does not require any reinsertions, but can include any number of redirections.
Measured: End of procedure, 1 per subject
Number of Redirections
Any forward movement of the needle in a new direction not preceded by withdrawal from the skin, counted until confirmation of spinal canal access can be assessed.
Measured: End of procedure, 1 per subject
Number of Passes
Any forward movement of the needle, calculated as the sum of insertions and redirections.
Measured: End of procedure, 1 per subject
Incidence of First-pass Success
A case that does not require reinsertions or redirections.
Measured: End of procedure, 1 per subject
Subject Discomfort During Landmarking
Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain.
Measured: End of procedure, 1 per subject
Provider Confidence With the Identified Insertion Site
Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.
Measured: End of procedure, 1 per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start4 Apr 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, parallel, randomized study design
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntuiTap Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796935
- Sponsor's protocol ID
- INT-001
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2021
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04796935
- Acronym / sponsor ID
- INT-001
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain
- Keywords
- Diagnostic spinal puncture, Therapeutic spinal puncture, Lumbar puncture, Epidural, Neuraxial anesthesia, Blood patch, ESI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- IntuiTap Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and therapeutic clinical scenarios.
The standard of care involves manual palpation of the patient's back to detect the spinous processes (SPs) and estimate the location of the interspinous needle insertion site. While providers are trained to perform these procedures with meticulous precision and attention to detail, this technique remains highly inaccurate, often requiring multiple insertion attempts to properly place the needle. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput.
The VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site.
Study participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, parallel, randomized study design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Experimental | Device: Tactile Imaging (VerTouch)VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. |
| Group 2: Control (palpation) | Active comparator | Other: Control (palpation)Palpation used to identify and mark an insertion site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 18 years and above, inclusive
- Subjects scheduled for one of the following procedures:
- Subjects having a BMI ≤42kg/m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental Group 1: Tactile Imaging (VerTouch) |
| Control (palpation)Control, palpation used to identify and mark an insertion site. | Other | Group 2: Control (palpation) |
Primary outcome
Number of Insertion Attempts
Time frame: End of procedure, 1 per participant
Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.
6 secondary outcomes
Incidence of First-insertion Success
Time frame: End of procedure, 1 per subject
Number of Redirections
Time frame: End of procedure, 1 per subject
Number of Passes
Time frame: End of procedure, 1 per subject
Incidence of First-pass Success
Time frame: End of procedure, 1 per subject
Subject Discomfort During Landmarking
Time frame: End of procedure, 1 per subject
Provider Confidence With the Identified Insertion Site
Time frame: End of procedure, 1 per subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile Imaging (VerTouch) in people with Central Nervous System Infections and Pseudotumor Cerebri, run by IntuiTap Medical, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Insertion Attempts (time frame: End of procedure, 1 per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.