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
NCT number | NCT04796935 |
Other study ID # | INT-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 4, 2021 |
Est. completion date | November 24, 2021 |
Verified date | November 2022 |
Source | IntuiTap Medical, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
Status | Completed |
Enrollment | 91 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center | Houston | Texas |
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
IntuiTap Medical, Inc | ICON plc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | Incidence of first-insertion success | A case that does not require any reinsertions, but can include any number of redirections. | End of procedure | |
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 | |
Secondary | Number of passes | Any forward movement of the needle, calculated as the sum of insertions and redirections. | End of procedure | |
Secondary | Incidence of first-pass success | A case that does not require reinsertions or redirections. | End of procedure | |
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 | |
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 |
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