NCT07458087

Accuracy of the Accuro 3S

Feasibility and Accuracy of the Accuro 3S

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Neuraxial Technique

Interventions

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

Timeline

• Start date: 2026-07-15
• Primary completion: 2028-01-15
• Completion: 2028-01-15
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study