Cancer, Central Nervous System Infections, Neurological Disorder, Obstetric Procedure Pain, Orthopedic Procedure Pain, Post-Dural Puncture Headache, Pseudotumor Cerebri
Conditions
Keywords
Diagnostic spinal puncture, Therapeutic spinal puncture, Lumbar puncture, Epidural, Neuraxial anesthesia, Blood patch, ESI
Brief summary
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.
Interventions
DEVICETactile 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.
OTHERControl (palpation)
Control, palpation used to identify and mark an insertion site.
Sponsors
ICON plc
IntuiTap Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
An open-label, parallel, randomized study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Insertion Attempts | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Redirections | 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. |
| Number of Passes | End of procedure, 1 per subject | Any forward movement of the needle, calculated as the sum of insertions and redirections. |
| Incidence of First-insertion Success | End of procedure, 1 per subject | A case that does not require any reinsertions, but can include any number of redirections. |
| Subject Discomfort During Landmarking | 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. |
| Provider Confidence With the Identified Insertion Site | 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. |
| Incidence of First-pass Success | End of procedure, 1 per subject | A case that does not require reinsertions or redirections. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Referral to Radiology | End of procedure, 1 per subject | 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. |
| Localization Time | 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. |
| Incidence of Post-dural Puncture Headache | Follow up, 3±2 days after procedure, 1 per subject | 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. |
| Incidence of Conversion From Spinal to Epidural | End of procedure, 1 per subject | A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia. |
| Insertion Time | End of procedure, 1 per subject | Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made. |
| Total Procedure Time | End of procedure, 1 per subject | From positioning of the patient to removal of the drape from the subject's back. |
| Bone Contacts | End of procedure, 1 per subject | Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed. |
| Incidence of Unintended Dural Puncture | 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). |
| Incidence of Paresthesia During Needle Insertion | End of procedure, 1 per subject | A case in which paresthesia is experienced during needle insertion. |
| Incidence of Traumatic Tap | End of procedure, 1 per subject | A case that results in visible blood aspiration. |
Countries
United States
Participant flow
Pre-assignment details
After enrollment, subjects meeting eligibility criteria were randomized; the rest were considered screen failures.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 48 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device not available | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Trained provider not available | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group 2: Control (Palpation) | Experimental Group 1: Tactile Imaging (VerTouch) |
|---|---|---|---|
| Age, Continuous ITT | 42.0 years STANDARD_DEVIATION 18.07 | 40.5 years STANDARD_DEVIATION 18.47 | 43.8 years STANDARD_DEVIATION 17.67 |
| Age, Continuous PP | 40.1 years STANDARD_DEVIATION 16.8 | 39.3 years STANDARD_DEVIATION 17.78 | 41.4 years STANDARD_DEVIATION 15.55 |
| Age, Customized ITT Adolescent (<22) | 5 Participants | 3 Participants | 2 Participants |
| Age, Customized ITT Middle-aged Adult (41-65) | 25 Participants | 10 Participants | 15 Participants |
| Age, Customized ITT Older Adult (>65) | 13 Participants | 7 Participants | 6 Participants |
| Age, Customized ITT Young Adult (22-40) | 47 Participants | 28 Participants | 19 Participants |
| Age, Customized PP Adolescent (<22) | 4 Participants | 3 Participants | 1 Participants |
| Age, Customized PP Middle-aged Adult (41-65) | 18 Participants | 8 Participants | 10 Participants |
| Age, Customized PP Older Adult (>65) | 7 Participants | 5 Participants | 2 Participants |
| Age, Customized PP Young Adult (22-40) | 37 Participants | 25 Participants | 12 Participants |
| BMI ITT | 29.5 kg/m^2 STANDARD_DEVIATION 6.24 | 29.4 kg/m^2 STANDARD_DEVIATION 6.56 | 29.6 kg/m^2 STANDARD_DEVIATION 5.94 |
| BMI PP | 29.3 kg/m^2 STANDARD_DEVIATION 6.37 | 29.5 kg/m^2 STANDARD_DEVIATION 6.37 | 29.0 kg/m^2 STANDARD_DEVIATION 6.1 |
| BMI, categorical ITT Class 1 Obesity (30-34.9) | 25 Participants | 12 Participants | 13 Participants |
| BMI, categorical ITT Class 2-3 Obesity (≥35) | 18 Participants | 10 Participants | 8 Participants |
| BMI, categorical ITT Normal (18.5-24.9) | 25 Participants | 15 Participants | 10 Participants |
| BMI, categorical ITT Overweight (25-29.9) | 20 Participants | 9 Participants | 11 Participants |
| BMI, categorical ITT Underweight (<18.5) | 1 Participants | 1 Participants | 0 Participants |
| BMI, categorical PP Class 1 Obesity (30-34.9) | 15 Participants | 10 Participants | 5 Participants |
| BMI, categorical PP Class 2-3 Obesity (≥35) | 14 Participants | 9 Participants | 5 Participants |
| BMI, categorical PP Normal (18.5-24.9) | 18 Participants | 12 Participants | 6 Participants |
| BMI, categorical PP Overweight (25-29.9) | 18 Participants | 9 Participants | 9 Participants |
| BMI, categorical PP Underweight (<18.5) | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) ITT Hispanic or Latino | 23 Participants | 14 Participants | 9 Participants |
| Ethnicity (NIH/OMB) ITT Not Hispanic or Latino | 66 Participants | 33 Participants | 33 Participants |
| Ethnicity (NIH/OMB) ITT Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) PP Hispanic or Latino | 18 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) PP Not Hispanic or Latino | 47 Participants | 28 Participants | 19 Participants |
| Ethnicity (NIH/OMB) PP Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Height ITT | 165.5 cm STANDARD_DEVIATION 9.93 | 165.3 cm STANDARD_DEVIATION 10.36 | 165.7 cm STANDARD_DEVIATION 9.53 |
| Height PP | 164.3 cm STANDARD_DEVIATION 9.79 | 164.8 cm STANDARD_DEVIATION 10.45 | 163.5 cm STANDARD_DEVIATION 8.74 |
| Race (NIH/OMB) ITT American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) ITT Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) ITT Black or African American | 18 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) ITT More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) ITT Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) ITT Unknown or Not Reported | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) ITT White | 59 Participants | 32 Participants | 27 Participants |
| Race (NIH/OMB) PP American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) PP Black or African American | 13 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) PP More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) PP Unknown or Not Reported | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) PP White | 45 Participants | 29 Participants | 16 Participants |
| Sex: Female, Male ITT Female | 65 Participants | 36 Participants | 29 Participants |
| Sex: Female, Male ITT Male | 25 Participants | 12 Participants | 13 Participants |
| Sex: Female, Male PP Female | 53 Participants | 32 Participants | 21 Participants |
| Sex: Female, Male PP Male | 13 Participants | 9 Participants | 4 Participants |
| Weight ITT | 81.0 kg STANDARD_DEVIATION 18.42 | 80.6 kg STANDARD_DEVIATION 17.71 | 81.6 kg STANDARD_DEVIATION 19.4 |
| Weight PP | 79.0 kg STANDARD_DEVIATION 17.97 | 79.9 kg STANDARD_DEVIATION 17.86 | 77.6 kg STANDARD_DEVIATION 18.44 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 48 |
| other Total, other adverse events | 2 / 42 | 1 / 48 |
| serious Total, serious adverse events | 0 / 42 | 0 / 48 |
Outcome results
Primary
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.
Time frame: End of procedure, 1 per participant
Population: Intent-to-Treat (ITT) includes all randomized subjects. Per-Protocol (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 specific outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Insertion Attempts | ITT | 1.8 insertions | Standard Deviation 0.26 |
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Insertion Attempts | PP | 1.2 insertions | Standard Deviation 0.66 |
| Group 2: Control (Palpation) | Number of Insertion Attempts | ITT | 2.2 insertions | Standard Deviation 0.3 |
| Group 2: Control (Palpation) | Number of Insertion Attempts | PP | 2.1 insertions | Standard Deviation 2.1 |
Secondary
Incidence of First-insertion Success
A case that does not require any reinsertions, but can include any number of redirections.
Time frame: End of procedure, 1 per subject
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of First-insertion Success | ITT | 25 Participants |
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of First-insertion Success | PP | 21 Participants |
| Group 2: Control (Palpation) | Incidence of First-insertion Success | ITT | 25 Participants |
| Group 2: Control (Palpation) | Incidence of First-insertion Success | PP | 25 Participants |
Secondary
Incidence of First-pass Success
A case that does not require reinsertions or redirections.
Time frame: End of procedure, 1 per subject
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of First-pass Success | ITT | 10 Participants |
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of First-pass Success | PP | 9 Participants |
| Group 2: Control (Palpation) | Incidence of First-pass Success | ITT | 9 Participants |
| Group 2: Control (Palpation) | Incidence of First-pass Success | PP | 9 Participants |
Secondary
Number of Passes
Any forward movement of the needle, calculated as the sum of insertions and redirections.
Time frame: End of procedure, 1 per subject
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Passes | ITT | 6.4 passes | Standard Deviation 6.66 |
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Passes | PP | 3.8 passes | Standard Deviation 3.49 |
| Group 2: Control (Palpation) | Number of Passes | ITT | 8.0 passes | Standard Deviation 9.78 |
| Group 2: Control (Palpation) | Number of Passes | PP | 7.3 passes | Standard Deviation 9.62 |
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.
Time frame: End of procedure, 1 per subject
Population: 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 specific outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Redirections | ITT | 4.5 redirections | Standard Deviation 5.6 |
| Experimental Group 1: Tactile Imaging (VerTouch) | Number of Redirections | PP | 2.5 redirections | Standard Deviation 3.14 |
| Group 2: Control (Palpation) | Number of Redirections | ITT | 5.8 redirections | Standard Deviation 8.44 |
| Group 2: Control (Palpation) | Number of Redirections | PP | 5.2 redirections | Standard Deviation 8.31 |
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.
Time frame: End of procedure, 1 per subject
Population: 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 specific outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Provider Confidence With the Identified Insertion Site | ITT | 3.6 score on a scale | Standard Deviation 1.43 |
| Experimental Group 1: Tactile Imaging (VerTouch) | Provider Confidence With the Identified Insertion Site | PP | 4.0 score on a scale | Standard Deviation 1.24 |
| Group 2: Control (Palpation) | Provider Confidence With the Identified Insertion Site | ITT | 4.2 score on a scale | Standard Deviation 0.97 |
| Group 2: Control (Palpation) | Provider Confidence With the Identified Insertion Site | PP | 4.2 score on a scale | Standard Deviation 0.97 |
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.
Time frame: End of procedure, 1 per subject
Population: 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 specific outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Subject Discomfort During Landmarking | ITT | 2.0 score on a scale | Standard Deviation 2.17 |
| Experimental Group 1: Tactile Imaging (VerTouch) | Subject Discomfort During Landmarking | PP | 1.5 score on a scale | Standard Deviation 1.66 |
| Group 2: Control (Palpation) | Subject Discomfort During Landmarking | ITT | 1.9 score on a scale | Standard Deviation 2.43 |
| Group 2: Control (Palpation) | Subject Discomfort During Landmarking | PP | 1.5 score on a scale | Standard Deviation 1.89 |
Other Pre-specified
Bone Contacts
Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.
Time frame: End of procedure, 1 per subject
Population: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Bone Contacts | 2.0 contacts | Standard Deviation 6.04 |
| Group 2: Control (Palpation) | Bone Contacts | 2.9 contacts | Standard Deviation 4.81 |
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.
Time frame: End of procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Conversion From Spinal to Epidural | 0 Participants |
| Group 2: Control (Palpation) | Incidence of Conversion From Spinal to Epidural | 0 Participants |
Other Pre-specified
Incidence of Paresthesia During Needle Insertion
A case in which paresthesia is experienced during needle insertion.
Time frame: End of procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Paresthesia During Needle Insertion | 8 Participants |
| Group 2: Control (Palpation) | Incidence of Paresthesia During Needle Insertion | 9 Participants |
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.
Time frame: Follow up, 3±2 days after procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Post-dural Puncture Headache | 9 Participants |
| Group 2: Control (Palpation) | Incidence of Post-dural Puncture Headache | 16 Participants |
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.
Time frame: End of procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Referral to Radiology | 4 Participants |
| Group 2: Control (Palpation) | Incidence of Referral to Radiology | 2 Participants |
Other Pre-specified
Incidence of Traumatic Tap
A case that results in visible blood aspiration.
Time frame: End of procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Traumatic Tap | 1 Participants |
| Group 2: Control (Palpation) | Incidence of Traumatic Tap | 4 Participants |
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).
Time frame: End of procedure, 1 per subject
Population: All randomized subjects with data for the safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Incidence of Unintended Dural Puncture | 0 Participants |
| Group 2: Control (Palpation) | Incidence of Unintended Dural Puncture | 0 Participants |
Other Pre-specified
Insertion Time
Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.
Time frame: End of procedure, 1 per subject
Population: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Insertion Time | 303.5 seconds | Standard Deviation 600.79 |
| Group 2: Control (Palpation) | Insertion Time | 301.8 seconds | Standard Deviation 390.73 |
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.
Time frame: End of procedure, 1 per subject
Population: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Localization Time | 197.3 seconds | Standard Deviation 247.03 |
| Group 2: Control (Palpation) | Localization Time | 170.3 seconds | Standard Deviation 300.12 |
Other Pre-specified
Total Procedure Time
From positioning of the patient to removal of the drape from the subject's back.
Time frame: End of procedure, 1 per subject
Population: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group 1: Tactile Imaging (VerTouch) | Total Procedure Time | 19.3 minutes | Standard Deviation 16.43 |
| Group 2: Control (Palpation) | Total Procedure Time | 20.5 minutes | Standard Deviation 28.03 |