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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796935
• Other study ID #: INT-001
• Status: Completed
• Phase: N/A
• Start date: April 4, 2021
• Est. completion date: November 24, 2021

Study information

• Verified date: June 2024
• Source: IntuiTap Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Texas Health Science Center	Houston	Texas
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
IntuiTap Medical, Inc	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Insertion Time	Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.	End of procedure, 1 per subject
Other	Total Procedure Time	From positioning of the patient to removal of the drape from the subject's back.	End of procedure, 1 per subject
Other	Bone Contacts	Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.	End of procedure, 1 per subject
Other	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).	End of procedure, 1 per subject
Other	Incidence of Paresthesia During Needle Insertion	A case in which paresthesia is experienced during needle insertion.	End of procedure, 1 per subject
Other	Incidence of Traumatic Tap	A case that results in visible blood aspiration.	End of procedure, 1 per subject
Other	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.	End of procedure, 1 per subject
Other	Incidence of Conversion From Spinal to Epidural	A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.	End of procedure, 1 per subject
Other	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.	Follow up, 3±2 days after procedure, 1 per subject
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.	End of procedure, 1 per participant
Secondary	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
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.	End of procedure, 1 per subject
Secondary	Number of Passes	Any forward movement of the needle, calculated as the sum of insertions and redirections.	End of procedure, 1 per subject
Secondary	Incidence of First-pass Success	A case that does not require reinsertions or redirections.	End of procedure, 1 per subject
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.	End of procedure, 1 per subject
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.	End of procedure, 1 per subject