Neuraxial TechniqueNCT07458087
Accuracy of the Accuro 3S
A study testing ACCURO 3S in people with Neuraxial Technique, run by Yale University at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural). The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuraxial Technique
- What is being tested?
- ACCURO 3S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). *Given our labor and delivery volume (~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population.
- No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
- The patient is English speaking.
- For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. *Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.
Who cannot join
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100, 000, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 18.5 kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Feasibility and Accuracy of the Accuro 3S
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Read the detailed description
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
- Conditions
- Neuraxial Technique
- Being tested
- ACCURO 3S
- Keywords
- regional anesthesia/analgesia, spinal anesthesia, epidural
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCURO 3SDevice
Provides anatomical guidance during the placement of needles or catheters using real-time visualization.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care and neuraxial guidance | Experimental | Spinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique. Receives: Device: ACCURO 3S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of needle attempts
Defined as the number of times the needle is inserted into patients back
Measured: At time of procedure, 1 day
Mean number of needle redirections
Defined as number of needle movements in a cephalad, caudal or lateral position.
Measured: At time of procedure, 1 day
Accuracy of device
The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm).
Measured: At time of procedure, 1 day
Secondary outcomes (1)
Patient satisfaction
Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction.
Measured: 20 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startOct 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuraxial TechniqueStudies of the same condition, open and under way.
- More trials run by Yale 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Anticipated 10 spinal and 40 epidural procedures.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Rivanna Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Antonio Gonzalez-Fiol, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458087
- Sponsor's protocol ID
- 2000036235
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2026
- Last updated
- 23 Sep 2026
- Results posted
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of the Accuro 3S
- ClinicalTrials.gov ID
- NCT07458087
- Acronym / sponsor ID
- 2000036235
- Conditions
- Neuraxial Technique
- Keywords
- regional anesthesia/analgesia, spinal anesthesia, epidural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Rivanna Medical, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Detailed description
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anticipated 10 spinal and 40 epidural procedures.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care and neuraxial guidance | Experimental | Device: ACCURO 3SSpinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). *Given our labor and delivery volume (~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population.
- No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
- The patient is English speaking.
- For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. *Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.
Key exclusion criteria (5 listed)
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100, 000, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 18.5 kg/m2.
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 |
|---|---|---|
| ACCURO 3SProvides anatomical guidance during the placement of needles or catheters using real-time visualization. | Device | Standard of Care and neuraxial guidance |
Primary outcome
Mean number of needle attempts
Time frame: At time of procedure, 1 day
Defined as the number of times the needle is inserted into patients back
Mean number of needle redirections
Time frame: At time of procedure, 1 day
Defined as number of needle movements in a cephalad, caudal or lateral position.
Accuracy of device
Time frame: At time of procedure, 1 day
The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm).
1 secondary outcome
Patient satisfaction
Time frame: 20 minutes post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Neuraxial Technique
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section
Cesarean Section (MeSH: D002585), Anesthesia, Spinal (MeSH: D000775)
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.
Antonio Gonzalez-Fiol, MD principal investigator
Yale 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 ACCURO 3S in people with Neuraxial Technique, run by Yale 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Gonzalez-Fiol, MD (203-785-2802, antonio.gonzalez-fiol@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of needle attempts (time frame: At time of procedure, 1 day). The study lists 3 primary outcomes in all. 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 23 Sep 2026.