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| Name | Class |
|---|---|
| Intuitap | UNKNOWN |
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This study will compare the VerTouch device to palpation and ultrasound (US) techniques used to identifying the anatomic landmarks and optimal location for neuraxial access. This trial of the VerTouch device will be compared to the gold standard of palpation and the commonly cited US techniques.
Thousands of neuraxial procedures are completed daily with over 12,000 done at Prentice Women's hospital last year. These procedures are not without difficulty and complication. The gold standard of palpation and blind advancement of the needle toward the spine can result in multiple insertions of the needle into the skin and redirections of the trajectory of that needle after insertion to avoid the bones of the spine protecting the spinal column. These insertions and redirections are not only time consuming while the patient is in an uncommon position, but they also cause dis-comfort and possibly lasting pain days after the procedure. In addition to the patient dynamics, when anatomical or positioning issues result in difficult neuraxial procedures the common teaching is to attempt US guided access. Unfortunately, not many proceduralist are trained in this modality and the additional materials needed to perform the procedure with US take time to gather and further prolong the procedure. Additionally, though the cost of US technology is getting more reasonable, it is still rather expensive and a barrier to utilization by many facilities around the country and the world. Often, after many attempts, the proceduralist accepts failure of the procedure and refers the patient to the interventional radiology (IR) or pain medicine specialist for completion of the procedure using radiation to visualize the spine. Note, this is not an option for pregnant women who are not eligible for radiation due to fetal concerns.
The VerTouch device offers a non-invasive, untethered, and non-radiation producing device that allows for the visualization of the underlying structures of the spine to determine ideal needle placement for neuraxial procedures. The output on the screen can also be visualized by other providers or senior proceduralist for assistance with best course of action for the procedure. The device does not cause discomfort to the patient and does not require any additional materials to be functional.
Study participants will be recruited from Prentice Women's Hospital (Northwestern Medicine). Pregnant patients tend to be healthy and without comorbidities, and the anesthesiologists who perform the neuraxial procedure tend to have significant experience. Non-pregnant patients tend to require neuraxial access for diagnostic or therapeutic purposes (i.e. not for the relief of labor pains), and therefore have comorbidities.
Labor & Delivery: Participants will be randomized to one of the three arms (palpation, US, or VerTouch).
This study has the potential to show that the VerTouch is more effective than palpation and as effective as US at defining the location for neuraxial procedure initiation and eventual success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: VerTouch for labor epidural or spinal anesthesia procedure | Experimental | VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
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| Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure | Active Comparator | Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
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| Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure | Active Comparator | Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure | Device | Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Redirections of the Needle | Primary endpoint is the number of redirections of the needle | End of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Reinsertions of the Needle | Secondary endpoint is the number of reinsertions of the needle. | 24 hours. |
| Total Procedure Time | Total neuraxial procedure time in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh Vaidyanathan, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital and Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure | Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2021 |
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Prospective randomized controlled trial
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Participant will be blinded to what procedure will be used to identify lumbar landmarks.
All devices will be in the room with the operator of the devices.
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| Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure | Device | Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
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| Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure | Other | Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
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| 24 hours |
| FG001 | Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure | Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| FG002 | Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure | VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure | VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| BG001 | Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure | Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| BG002 | Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure | Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI = Weight (kg) / Height (m)² | Mean | Full Range | kg/m^2 |
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| Height (in) | Mean | Full Range | Inches |
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| Weight (Kilograms) | Mean | Full Range | Kilograms |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Redirections of the Needle | Primary endpoint is the number of redirections of the needle | Posted | Mean | Standard Deviation | Number of redirections of needle | End of procedure |
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| Secondary | Number of Reinsertions of the Needle | Secondary endpoint is the number of reinsertions of the needle. | Posted | Mean | Standard Deviation | Number of needle insertions | 24 hours. |
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| Secondary | Total Procedure Time | Total neuraxial procedure time in minutes | Posted | Mean | Standard Deviation | Minutes | 24 hours |
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24 hours after the neuraxial procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure | VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | 0 | 32 | 0 | 32 | 0 | 32 |
| EG001 | Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure | Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure | Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | 0 | 28 | 0 | 28 | 0 | 28 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
| Jul 29, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-Hispanic |
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| Not reported |
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