PregnancyNCT04630171
VerTouch Device: A Prospective Randomized Controlled Trial
A study testing Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure and Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in people with Pregnancy and Pain, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure and Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years old and above
- Undergoing a neuraxial procedure
Who cannot join
- Non English speaking
- Plastic allergy
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital and Prentice Women's Hospital
Chicago, Illinois, 60611
About this study
Official title: Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures When Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Group #1: VerTouch 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, Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure
- Keywords
- Pregnancy, Neuraxial Anesthesia, Therapeutic Lumbar Puncture, Ultrasound, Labor epidural, Spinal Procedure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedureDevice
Also called Group 1
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedureDevice
Also called Group 2
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedureOther
Also called Group 3
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure |
| 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. Receives: Device: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure |
| 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. Receives: Other: Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Redirections of the Needle
Primary endpoint is the number of redirections of the needle
Measured: End of procedure
Secondary outcomes (2)
Number of Reinsertions of the Needle
Secondary endpoint is the number of reinsertions of the needle.
Measured: 24 hours.
Total Procedure Time
Total neuraxial procedure time in minutes
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jan 2021
- Primary completion28 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitap
- Responsible party
- Principal investigator, Mahesh Vaidyanathan, Northwestern University
- Investigators
- Mahesh Vaidyanathan, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630171
- Sponsor's protocol ID
- STU00213282
- Status last verified
- Aug 2025
- First submitted
- 12 Nov 2020
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures When Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04630171
- Acronym / sponsor ID
- STU00213282
- Keywords
- Pregnancy, Neuraxial Anesthesia, Therapeutic Lumbar Puncture, Ultrasound, Labor epidural, Spinal Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Intuitap
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: VerTouch for labor epidural or spinal anesthesia procedure | Experimental | Device: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedureVerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
| Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure | Active comparator | Device: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedureUltrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
| Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure | Active comparator | Other: Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedureControl group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 18 years old and above
- Undergoing a neuraxial procedure
Key exclusion criteria (3 listed)
- Non English speaking
- Plastic allergy
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedureAlso: Group 1Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | Device | Group 1: VerTouch for labor epidural or spinal anesthesia procedure |
| Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedureAlso: Group 2Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | Device | Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure |
| Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedureAlso: Group 3Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia | Other | Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure |
Primary outcome
Number of Redirections of the Needle
Time frame: End of procedure
Primary endpoint is the number of redirections of the needle
2 secondary outcomes
Number of Reinsertions of the Needle
Time frame: 24 hours.
Total Procedure Time
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahesh Vaidyanathan, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure and Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in people with Pregnancy and Pain, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Redirections of the Needle (time frame: End of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.