Who is sponsoring NCT04796935?

NCT04796935 is sponsored by IntuiTap Medical, Inc.

What drugs are being tested in NCT04796935?

Interventions in NCT04796935: Tactile Imaging (VerTouch), Control (palpation).

What condition does NCT04796935 study?

NCT04796935 studies Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer, Obstetric Procedure Pain, Orthopedic Procedure Pain, Post-Dural Puncture Headache.

Is NCT04796935 still recruiting?

NCT04796935 is currently completed. Last updated 11 June 2024.

Are results published for NCT04796935?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-11 · How we verify

NCT04796935

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 11 June 2024

What this trial tests

NA trial testing Tactile Imaging (VerTouch) in Central Nervous System Infections in 95 participants. Completed in 24 November 2021.

Timeline

4 April 2021

Primary endpoint
24 November 2021

24 November 2021

Quick facts

Lead sponsor	IntuiTap Medical, Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	95
Start date	4 April 2021
Primary completion	24 November 2021
Estimated completion	24 November 2021
Sites	3 locations across United States

Drugs / interventions tested

Tactile Imaging (VerTouch)
Control (palpation)

Conditions studied

Central Nervous System Infections — all drugs for Central Nervous System Infections →
Pseudotumor Cerebri — all drugs for Pseudotumor Cerebri →
Neurological Disorder — all drugs for Neurological Disorder →
Cancer — all drugs for Cancer →

Sponsor

IntuiTap Medical, Inc

Who can join

18 and older, any sex, with Central Nervous System Infections or Pseudotumor Cerebri. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Insertion Attempts Primary · 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.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	1.8	± 0.26
Group 2: Control (Palpation)	2.2	± 0.3

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	1.2	± 0.66
Group 2: Control (Palpation)	2.1	± 2.10

Incidence of First-insertion Success Secondary · End of procedure, 1 per subject

A case that does not require any reinsertions, but can include any number of redirections.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	25
Group 2: Control (Palpation)	25

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	21
Group 2: Control (Palpation)	25

Number of Redirections Secondary · End of procedure, 1 per subject

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.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	4.5	± 5.60
Group 2: Control (Palpation)	5.8	± 8.44

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	2.5	± 3.14
Group 2: Control (Palpation)	5.2	± 8.31

Number of Passes Secondary · End of procedure, 1 per subject

Any forward movement of the needle, calculated as the sum of insertions and redirections.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	6.4	± 6.66
Group 2: Control (Palpation)	8.0	± 9.78

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	3.8	± 3.49
Group 2: Control (Palpation)	7.3	± 9.62

Incidence of First-pass Success Secondary · End of procedure, 1 per subject

A case that does not require reinsertions or redirections.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	10
Group 2: Control (Palpation)	9

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	9
Group 2: Control (Palpation)	9

Subject Discomfort During Landmarking Secondary · End of procedure, 1 per subject

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.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	2.0	± 2.17
Group 2: Control (Palpation)	1.9	± 2.43

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	1.5	± 1.66
Group 2: Control (Palpation)	1.5	± 1.89

Provider Confidence With the Identified Insertion Site Secondary · End of procedure, 1 per subject

Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.

ITT

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	3.6	± 1.43
Group 2: Control (Palpation)	4.2	± 0.97

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	4.0	± 1.24
Group 2: Control (Palpation)	4.2	± 0.97

Localization Time Secondary · End of procedure, 1 per subject

Time from first touch of draped patient to identification of an insertion site; for VerTouch, this is the time from VerTouch device placement to movement of the applicator to the identified insertion site.

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	197.3	± 247.03
Group 2: Control (Palpation)	170.3	± 300.12

Insertion Time Secondary · End of procedure, 1 per subject

Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	303.5	± 600.79
Group 2: Control (Palpation)	301.8	± 390.73

Total Procedure Time Secondary · End of procedure, 1 per subject

From positioning of the patient to removal of the drape from the subject's back.

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	19.3	± 16.43
Group 2: Control (Palpation)	20.5	± 28.03

Bone Contacts Secondary · End of procedure, 1 per subject

Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	2.0	± 6.04
Group 2: Control (Palpation)	2.9	± 4.81

Incidence of Unintended Dural Puncture Secondary · End of procedure, 1 per subject

A case that results in puncture of the dura when it is not intended (i.e., in an epidural procedure).

Group	Value	95% CI
Experimental Group 1: Tactile Imaging (VerTouch)	0
Group 2: Control (Palpation)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3±2 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Group 1: Tactile Imaging (VerTouch)

Serious: 0/42 (0%)

Deaths: 0/42

Group 2: Control (Palpation)

Serious: 0/48 (0%)

Deaths: 0/48

Other adverse events (3 terms — click to expand)

Reaction	System	Experimental Group 1: Tact…	Group 2: Control (Palpation)
Syncope	Nervous system disorders	—	—
Hemorrhage	Blood and lymphatic system disorders	—	—
Back and Shoulder Pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04796935 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04796935 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IntuiTap Medical, Inc
Last refreshed: 11 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04796935.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing