NCT03164369

Brief Summary

The aim of this double blinded study is to assess the abilities of the SpineNav3DTM technology (Accuro) to identify the lumbar epidural space in parturients using as comparator a standar ultrasound (US) device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

May 22, 2017

Last Update Submit

May 23, 2017

Conditions

Ultrasound

Keywords

epidural block, ultrasound

Outcome Measures

Primary Outcomes (1)

  • epidural space depth

    measurement of the depth of the epidural space

    day 1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy single fetus pregnant

You may qualify if:

  • Healthy pregnant women undergoing antenatal anesthetic consultation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citta di Roma Hospital

Rome, 00152, Italy

Location

Study Officials

  • Giorgio Capogna, MD

    Citta di Roma Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Department of Anesthesia

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

April 1, 2017

Primary Completion

May 2, 2017

Study Completion

May 2, 2017

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)