Back to results3D Personalized Modelization of the Hand Using EOS Imaging System (M3DME)
Primary Purpose
Hand Injuries
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS hand imaging
Sponsored by
About this trial
This is an interventional other trial for Hand Injuries
Eligibility Criteria
Inclusion Criteria:
- Patient with hand/wrist CT required
- Informed consent form signed
Sites / Locations
- CHU de BesançonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EOS imaging
Arm Description
For each patient, EOS images are compared with computed tomography [CT] images
Outcomes
Primary Outcome Measures
Data obtained through EOS imaging
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Data obtained through standard CT
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Secondary Outcome Measures
Full Information
NCT ID
NCT04895891
First Posted
May 17, 2021
Last Updated
May 19, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT04895891
Brief Title
3D Personalized Modelization of the Hand Using EOS Imaging System
Acronym
M3DME
Official Title
3D Personalized Modelization of the Hand Using EOS Imaging System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EOS imaging
Arm Type
Experimental
Arm Description
For each patient, EOS images are compared with computed tomography [CT] images
Intervention Type
Device
Intervention Name(s)
EOS hand imaging
Intervention Description
For each patient, EOS images are compared with CT images
Primary Outcome Measure Information:
Title
Data obtained through EOS imaging
Description
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Time Frame
Day 60
Title
Data obtained through standard CT
Description
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Time Frame
Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with hand/wrist CT required
Informed consent form signed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Loisel, MD
Phone
0033381667540
Email
floisel@chu-besancon.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Loisel, MD
First Name & Middle Initial & Last Name & Degree
François Loisel, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D Personalized Modelization of the Hand Using EOS Imaging System
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