A Study to Test Performance of Needle Placements for Neur... | NCT04796935

NCT04796935

Status Module

Name	Class
ICON plc	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group 1: Tactile Imaging (VerTouch)	Experimental	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.	Device: Tactile Imaging (VerTouch)
Group 2: Control (palpation)	Active Comparator	Palpation used to identify and mark an insertion site.	Other: Control (palpation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	End of procedure, 1 per participant

Secondary Outcomes

Measure	Description	Time Frame
Incidence of First-insertion Success	A case that does not require any reinsertions, but can include any number of redirections.	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.

Other Outcomes

Measure	Description	Time Frame
Localization Time	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.	End of procedure, 1 per subject
Insertion Time

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02903	United States
Medical University of South Carolina

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 25, 2020	Jul 6, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
BG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00042 BG00148 BG00290

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.

Mean

Standard Deviation

years

Title

Denominators

Categories

ITT

- ParticipantsOG00036
- ParticipantsOG00146

Title	Measurements
	OG0001.8± 0.26

Secondary

Incidence of First-insertion Success

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

ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data recorded for the related outcome measure (insertions).

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

redirections

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Secondary

Number of Passes

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

ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions and redirections).

Posted

Mean

Standard Deviation

passes

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Secondary

Incidence of First-pass Success

A case that does not require reinsertions or redirections.

ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions, redirections).

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Other Pre-specified

Localization Time

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.

PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.

Posted

Mean

Standard Deviation

seconds

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Other Pre-specified

Insertion Time

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

PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.

Posted

Mean

Standard Deviation

seconds

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Total Procedure Time

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

PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.

Posted

Mean

Standard Deviation

minutes

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Bone Contacts

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

PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.

Posted

Mean

Standard Deviation

contacts

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Unintended Dural Puncture

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

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Paresthesia During Needle Insertion

A case in which paresthesia is experienced during needle insertion.

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Traumatic Tap

A case that results in visible blood aspiration.

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Referral to Radiology

A case in which the provider cannot perform the procedure at the bedside and refers the subject to radiology for the procedure to be completed under fluoroscopic guidance.

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Other Pre-specified

Incidence of Conversion From Spinal to Epidural

A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

End of procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants	OG000

Other Pre-specified

Incidence of Post-dural Puncture Headache

A case that results in the patient experiencing one or more headache of any level of severity after the procedure and/or at follow-up.

All randomized subjects with data for the safety endpoint.

Posted

Count of Participants

Participants

Follow up, 3±2 days after procedure, 1 per subject

ID	Title	Description
OG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.
OG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental Group 1: Tactile Imaging (VerTouch)	VerTouch used to identify and mark, or begin placement of a needle, at an insertion site. 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.	0	42	0	42	2	42
EG001	Group 2: Control (Palpation)	Palpation used to identify and mark an insertion site. Control (palpation): Control, palpation used to identify and mark an insertion site.	0	48	0	48	1	48

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Syncope	Nervous system disorders	Non-systematic Assessment	VerTouch Group: determined unlikely to be related to device	EG0001 events1 affected42 at risk EG0010 events0 affected48 at risk
Hemorrhage	Blood and lymphatic system disorders	Non-systematic Assessment	VerTouch Group: determined unrelated to device	EG0001 events1 affected42 at risk EG0010 events0 affected48 at risk
Back and Shoulder Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	Palpation Arm: may have been related to study procedure but not study device (control group)	EG0000 events0 affected42 at risk EG0011 events1 affected48 at risk

The enrollment period (April 2021-November 2021) was closed due to COVID concerns prior to reaching 96 evaluable subjects. Due to limitations in the emergency medicine setting at one site, emergency medicine providers at that site performed procedures for approximately half of the subjects enrolled in that site's neurology setting. Due to scheduling limitations, only MDs (including residents) performed procedures, and not all providers had the opportunity to use the device more than once.

ID	Term
D002494	Central Nervous System Infections
D011559	Pseudotumor Cerebri
D009422	Nervous System Diseases
D009369	Neoplasms
D051299	Post-Dural Puncture Headache

ID	Term
D007239	Infections
D002493	Central Nervous System Diseases
D019586	Intracranial Hypertension
D001927	Brain Diseases
D051271	Headache Disorders, Secondary
D020773	Headache Disorders