M3DME: 3D Personalized Modelization of the Hand Using EOS Imaging System
Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04895891
Collaborator
(none)
60
1
1
61.8
1
Study Details
Study Description
Brief Summary
This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
3D Personalized Modelization of the Hand Using EOS Imaging System
Actual Study Start Date
:
Oct 6, 2020
Anticipated Primary Completion Date
:
Dec 1, 2025
Anticipated Study Completion Date
:
Dec 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EOS imaging For each patient, EOS images are compared with computed tomography [CT] images |
Device: EOS hand imaging
For each patient, EOS images are compared with CT images
|
Outcome Measures
Primary Outcome Measures
- Data obtained through EOS imaging [Day 60]
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
- Data obtained through standard CT [Day 60]
Precision and correlation of the 3D modelization of hand is compared between the two imaging methods
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient with hand/wrist CT required
-
Informed consent form signed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Besançon | Besançon | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04895891
Other Study ID Numbers:
- P/2019/444
First Posted:
May 20, 2021
Last Update Posted:
May 20, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: