Accuracy of the Accuro 3S

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07458087
Status
Not Yet Recruiting

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Conditions

  • Neuraxial Technique

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • ACCURO 3S — DEVICE
    Provides anatomical guidance during the placement of needles or catheters using real-time visualization.

Study Details

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.

Key Dates

Start date
Jul 15, 2026
Status verified
Mar 2026
Primary completion
Jan 15, 2028
Completion
Jan 15, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Standard of Care and neuraxial guidance
    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.

Primary Outcome Measure

Mean number of needle attempts [ Time Frame: At time of procedure, 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520-

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