Back to resultsPerformance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner (PELVI-EOS)
Primary Purpose
Radiation, Obstetric Labor Complications, Pregnancy Complications
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS and CT Exam
Sponsored by
About this trial
This is an interventional diagnostic trial for Radiation focused on measuring EOS imagery
Eligibility Criteria
Inclusion Criteria:
- pelviscanner indication in women
Exclusion Criteria:
- In the disqualification of another study or under the "national register of volunteers."
Sites / Locations
- CHRU de Besançon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EOS and CT Exam
Arm Description
EOS and CT Examen for pregnant women in the 8th month of pregnancy
Outcomes
Primary Outcome Measures
Measurement reliability index Magnin with EOS cab relative to the CT measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT02834897
First Posted
July 13, 2016
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02834897
Brief Title
Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner
Acronym
PELVI-EOS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 12, 2016 (Actual)
Study Completion Date
February 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation, Obstetric Labor Complications, Pregnancy Complications
Keywords
EOS imagery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EOS and CT Exam
Arm Type
Experimental
Arm Description
EOS and CT Examen for pregnant women in the 8th month of pregnancy
Intervention Type
Radiation
Intervention Name(s)
EOS and CT Exam
Intervention Description
EOS and CT Examen for pregnant women in the 8th month of pregnancy
Primary Outcome Measure Information:
Title
Measurement reliability index Magnin with EOS cab relative to the CT measurements
Time Frame
one months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pelviscanner indication in women
Exclusion Criteria:
In the disqualification of another study or under the "national register of volunteers."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sebastien AUBRY, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Besançon
City
Besancon
ZIP/Postal Code
25000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner
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