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The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device

NCT05909085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-15

No results posted yet for this study

Summary

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

Conditions

  • Labor Analgesia

Interventions

DEVICE

Traditional ultrasound

Labor epidural will be performed after marking patient skin using traditional ultrasound guidance

DEVICE

Automated ultrasound

Labor epidural will be performed after marking patient skin using an automated ultrasound device

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Antonio Gonzalez, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909085 on ClinicalTrials.gov