Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner (PELVI-EOS)

July 17, 2018 updated by: Centre Hospitalier Universitaire de Besancon
The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHRU De Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pelviscanner indication in women

Exclusion Criteria:

  • In the disqualification of another study or under the "national register of volunteers."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EOS and CT Exam
EOS and CT Examen for pregnant women in the 8th month of pregnancy
Radiation: EOS and CT Exam
EOS and CT Examen for pregnant women in the 8th month of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement reliability index Magnin with EOS cab relative to the CT measurements
Time Frame: one months
one months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: sebastien AUBRY, MD, Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 12, 2016

Study Completion (Actual)

February 12, 2016

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2014/236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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